MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-12-11 for COBAN 2 LITE LAYER COMPRESSION SYSTEM 2794 manufactured by 3m Health Care.
[94468122]
Pulmonary embolism occurs at a known rate postoperatively following joint replacement surgery. When the report was received on (b)(6) 2017, there was no evidence to suggest that the occurrence of the pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty. On (b)(6) 2017 3m received the 4th report of a pulmonary embolism in this study. 3m contacted the study investigators to obtain additional patient details regarding operative duration, patient comorbidities and medical history. No additional information has been received to date. Although there was still no evidence to suggest that the occurrence of pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty, on (b) (6)2017 3m made the decision to send mdr reports for all four cases. 2110898-2017-000146 was sent for report received on (b)(4) 2017. On (b)(4) 2017 mdr report numbers 2110898-2017-00148, 2110898-2017-00149 and 2110898-2017-00150 were sent based on trend analysis. H6 conclusion code 20 (inconclusive- investigation in progress) was used. There was no conclusive evidence that the occurrence of a pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty. 3m will continue to monitor complaints and trends for this type of report.
Patient Sequence No: 1, Text Type: N, H10
[94468123]
An independent study investigator reported coban 2 lite layer compression system was applied to a (b)(6) female patient following a total knee arthroplasty. A research team member reportedly discovered the patient experienced a pulmonary embolism on post op day four when they were completing the two week follow-up phone interview.
Patient Sequence No: 1, Text Type: D, B5
[106423830]
3m received a formal letter from the (b)(6) regarding their investigation of the four pulmonary embolisms that occurred within the investigator-initiated research study entitled "the use of 3m? Coban? 2 lite layer compression system post-total knee arthroplasty". The (b)(6) consulted with two independent content experts to investigate the etiology of the pulmonary embolisms and to determine whether they were related to the study intervention, i. E. , the 3m? Coban? 2 lite layer compression system. In brief, the independent content experts reached consensus that the four pes were likely unrelated to the study intervention 3m? Coban? 2 lite layer compression system. - [3m coban study_pe investigation letter_mar 21 2018. Pdf].
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2017-00149 |
| MDR Report Key | 7107289 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-12-11 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-06-05 |
| Date Mfgr Received | 2017-12-05 |
| Date Added to Maude | 2017-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS KAREN KRENIK, BSN |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517333091 |
| Manufacturer G1 | MANUFACTURING MEDICAL DEVICES |
| Manufacturer Street | EDISONSTRASSE 6 D-59157 |
| Manufacturer City | KAMEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAN 2 LITE LAYER COMPRESSION SYSTEM |
| Generic Name | COBAN 2 LITE LAYER COMPRESSION SYSTEM |
| Product Code | FQM |
| Date Received | 2017-12-11 |
| Catalog Number | 2794 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-11 |