MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-26 for CASCADE AUTOLOGOUS PLATELET SYSTEM 910046 manufactured by Musculoskeletal Tissue Foundation (mtf).
[20006107]
All 3 occurrences involve reaction a few hours s/p (b)(4) 2013 injection to the right knee joint of the pts. All 3 occurrences involved cascade autologous platelet system kits of the same product and lot numbers. A 4th kit of the same product and lot number was used for the left knee of one of the pts, for which there wasn't a reaction to the injection. On (b)(6) 2013, three (3) pts of dr brian halpern were injected for knee oa with prp prepared with use of the cascade autologous platelet system. The same lot number of product (b)(4) was used, lot# 107692 for the four (4) total injections. Patient (b)(6) year-old female, received bilateral injections to her knee joints. Patient (b)(6)-year old female, received injection to her right knee joint. Patient (b)(6) year-old female, received injection to her right knee joint. Info has been obtained from the following sources: surgical consultant (b)(6) and marketing director (b)(6) from the distributor/partner of mtf, conmed/linvatec came to hss (b)(6) 2013. Dr (b)(6) and his office manager (b)(6). Director of regulatory affairs for mtf and medical director (infectious disease specialty) for mtf (b)(6), md via conference call (b)(6) 2013. Discussions with multiple hss departments: operating room materials mgmt, sports medicine dept, materials mgmt. All three (3) pts called dr. (b)(6)'s office complaining of pain, swelling and warmth of their right knees within a few hours of the injections. The pt who had bilateral injections did not experience a problem on the left side. (b)(6) were referred to (b)(6) er, where they were admitted to the orthopedic service, both with diagnoses of "acute right knee effusion/pain. " both were treated with antibiotics. Both were discharged home on (b)(6) 2013, and will come to dr (b)(6) 2013. (b)(6) came in to dr's office on (b)(6) 2013. The pt's synovial fluid cell count revealed wbc and rbc elevated, with no organisms seen on gram stain. The two pts admitted to (b)(6) also had elevated aspiration cell counts. No prp injections using the cascade sys administered by dr (b)(6) prior to the three (3) injections on (b)(6) 2013 were of the same lot number. Pts who were administered prp injections by him during the prior month were contacted by his office and none reported a problem as of (b)(6) 2013. The kits are stored on a shelf in the office manager's office. The room temperature had remained constant over the weekend. Dr (b)(6) did all four (4) injections in exactly the same manner he always does. He does the procedure himself, after the nurse preps the pt, draws the blood, and does the spinning. He then administers the injection himself after freezing with ethyl chloride. There was no difference in how the procedure was done to the two knees of the pt who received bilateral injections. None of the pts received any other injection or treatment to the knees aside from the prp injection. All hss offices that have stock of the mtf prp kits have removed any kits they have from availability for use. Dr (b)(6) has approx 7 kits remaining of the lot number in question. Mtf will be having these kits returned to them for analysis. Dr (b)(6) also has 3 kits of different lot numbers, which he will not be using. Mtf is exploring distribution and use of product# (b)(4), lot# 107692. It was decided to stop use of all cascade autologous platelet system products used for prp injection mfg by mtf, pending the final investigation outcome. Notification from the surgeon-in-chief was distributed to all medical staff and clinical division chiefs.
Patient Sequence No: 1, Text Type: D, B5
[20124149]
All 3 occurrences involve reaction a few hours s/p (b)(4) 2013 injection to the right knee joint of the pts. All 3 occurrences involved cascade autologous platelet system kits of the same product and lot numbers. A 4th kit of the same product and lot number was used for the left knee of one of the pts, for which there wasn't a reaction to the injection. On (b)(6) 2013, three (3) pts of dr brian halpern were injected for knee oa with prp prepared with use of the cascade autologous platelet system. The same lot number of product (b)(4) was used, lot# 107692 for the four (4) total injections. Patient (b)(6) year-old female, received bilateral injections to her knee joints. Patient (b)(6)-year old female, received injection to her right knee joint. Patient (b)(6) year-old female, received injection to her right knee joint. Info has been obtained from the following sources: surgical consultant (b)(6) and marketing director (b)(6) from the distributor/partner of mtf, conmed/linvatec came to hss (b)(6) 2013. Dr (b)(6) and his office manager (b)(6). Director of regulatory affairs for mtf and medical director (infectious disease specialty) for mtf (b)(6), md via conference call (b)(6) 2013. Discussions with multiple hss departments: operating room materials mgmt, sports medicine dept, materials mgmt. All three (3) pts called dr. (b)(6)'s office complaining of pain, swelling and warmth of their right knees within a few hours of the injections. The pt who had bilateral injections did not experience a problem on the left side. (b)(6) were referred to (b)(6) er, where they were admitted to the orthopedic service, both with diagnoses of "acute right knee effusion/pain. " both were treated with antibiotics. Both were discharged home on (b)(6) 2013, and will come to dr (b)(6) 2013. (b)(6) came in to dr's office on (b)(6) 2013. The pt's synovial fluid cell count revealed wbc and rbc elevated, with no organisms seen on gram stain. The two pts admitted to (b)(6) also had elevated aspiration cell counts. No prp injections using the cascade sys administered by dr (b)(6) prior to the three (3) injections on (b)(6) 2013 were of the same lot number. Pts who were administered prp injections by him during the prior month were contacted by his office and none reported a problem as of (b)(6) 2013. The kits are stored on a shelf in the office manager's office. The room temperature had remained constant over the weekend. Dr (b)(6) did all four (4) injections in exactly the same manner he always does. He does the procedure himself, after the nurse preps the pt, draws the blood, and does the spinning. He then administers the injection himself after freezing with ethyl chloride. There was no difference in how the procedure was done to the two knees of the pt who received bilateral injections. None of the pts received any other injection or treatment to the knees aside from the prp injection. All hss offices that have stock of the mtf prp kits have removed any kits they have from availability for use. Dr (b)(6) has approx 7 kits remaining of the lot number in question. Mtf will be having these kits returned to them for analysis. Dr (b)(6) also has 3 kits of different lot numbers, which he will not be using. Mtf is exploring distribution and use of product# (b)(4), lot# 107692. It was decided to stop use of all cascade autologous platelet system products used for prp injection mfg by mtf, pending the final investigation outcome. Notification from the surgeon-in-chief was distributed to all medical staff and clinical division chiefs.
Patient Sequence No: 2, Text Type: D, B5
[20127380]
All 3 occurrences involve reaction a few hours s/p (b)(4) 2013 injection to the right knee joint of the pts. All 3 occurrences involved cascade autologous platelet system kits of the same product and lot numbers. A 4th kit of the same product and lot number was used for the left knee of one of the pts, for which there wasn't a reaction to the injection. On (b)(6) 2013, three (3) pts of dr brian halpern were injected for knee oa with prp prepared with use of the cascade autologous platelet system. The same lot number of product (b)(4) was used, lot# 107692 for the four (4) total injections. Patient (b)(6) year-old female, received bilateral injections to her knee joints. Patient (b)(6)-year old female, received injection to her right knee joint. Patient (b)(6) year-old female, received injection to her right knee joint. Info has been obtained from the following sources: surgical consultant (b)(6) and marketing director (b)(6) from the distributor/partner of mtf, conmed/linvatec came to hss (b)(6) 2013. Dr (b)(6) and his office manager (b)(6). Director of regulatory affairs for mtf and medical director (infectious disease specialty) for mtf (b)(6), md via conference call (b)(6) 2013. Discussions with multiple hss departments: operating room materials mgmt, sports medicine dept, materials mgmt. All three (3) pts called dr. (b)(6)'s office complaining of pain, swelling and warmth of their right knees within a few hours of the injections. The pt who had bilateral injections did not experience a problem on the left side. (b)(6) were referred to (b)(6) er, where they were admitted to the orthopedic service, both with diagnoses of "acute right knee effusion/pain. " both were treated with antibiotics. Both were discharged home on (b)(6) 2013, and will come to dr (b)(6) 2013. (b)(6) came in to dr's office on (b)(6) 2013. The pt's synovial fluid cell count revealed wbc and rbc elevated, with no organisms seen on gram stain. The two pts admitted to (b)(6) also had elevated aspiration cell counts. No prp injections using the cascade sys administered by dr (b)(6) prior to the three (3) injections on (b)(6) 2013 were of the same lot number. Pts who were administered prp injections by him during the prior month were contacted by his office and none reported a problem as of (b)(6) 2013. The kits are stored on a shelf in the office manager's office. The room temperature had remained constant over the weekend. Dr (b)(6) did all four (4) injections in exactly the same manner he always does. He does the procedure himself, after the nurse preps the pt, draws the blood, and does the spinning. He then administers the injection himself after freezing with ethyl chloride. There was no difference in how the procedure was done to the two knees of the pt who received bilateral injections. None of the pts received any other injection or treatment to the knees aside from the prp injection. All hss offices that have stock of the mtf prp kits have removed any kits they have from availability for use. Dr (b)(6) has approx 7 kits remaining of the lot number in question. Mtf will be having these kits returned to them for analysis. Dr (b)(6) also has 3 kits of different lot numbers, which he will not be using. Mtf is exploring distribution and use of product# (b)(4), lot# 107692. It was decided to stop use of all cascade autologous platelet system products used for prp injection mfg by mtf, pending the final investigation outcome. Notification from the surgeon-in-chief was distributed to all medical staff and clinical division chiefs.
Patient Sequence No: 3, Text Type: D, B5
| Report Number | 3313046 |
| MDR Report Key | 3313046 |
| Date Received | 2013-08-26 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-07-15 |
| Date Facility Aware | 2013-07-15 |
| Report Date | 2013-07-17 |
| Date Reported to Mfgr | 2013-07-17 |
| Date Added to Maude | 2013-08-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASCADE AUTOLOGOUS PLATELET SYSTEM |
| Generic Name | PRP (PLATELET RICH PLASMA) SYSTEM/KIT |
| Product Code | ORG |
| Date Received | 2013-08-26 |
| Model Number | 910046 |
| Lot Number | 107692 |
| ID Number | 4 KITS OF SAME #S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUSCULOSKELETAL TISSUE FOUNDATION (MTF) |
| Manufacturer Address | EDISON NJ 08873 US 08873 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-08-26 |
| 2 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-08-26 |
| 3 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-08-26 |