MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2017-07-27 for MICROMATRIX MM0030 manufactured by Acell, Inc..
[81234749]
A review of the manufacturing records for the lot identified no substantial deviations from the validated processes and demonstrated the product was manufactured and distributed in compliance with fda, state, local and manufacturer operating procedures. Biocompatibility testing per iso 10993 has demonstrated that this product line does not cause adverse responses in test subjects. Usage of this product for hair loss is off label. Due to the subsequent medical intervention and out of an abundance of caution this mdr has been filed.
Patient Sequence No: 1, Text Type: N, H10
[81234750]
On (b)(6) 2017 physician injected mixture of platelet rich plasma and micromatrix powder into the scalp area. On (b)(6) 2017 patient returned to the clinic to voice some concerns, and was referred to a dermatologist. Patient stated she was having a reaction and described the area was very painful, there was soreness, but no redness in area, her hair seemed "electric" and began to fall out. Patient claimed no allergies to pork or other substances. Dermatologist ruled out lichenoid reaction. On (b)(6) 2017 patient returned to the clinic with continued complaints, and had skin test performed by original treating physician. On (b)(6) 2017 original treating physician noted that patient had a mildly positive reaction which was described as "red and raised area" by the patient. Per the patient, her primary care physician prescribed antihistamines, and benadryl for sleep. On (b)(6) 2017 it was noted by original treating physician that the redness was resolved, and, based on past history of duloxetine use duloxetine was restarted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2017-00004 |
| MDR Report Key | 6748995 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-07-27 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-02 |
| Date Mfgr Received | 2017-06-28 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2017-07-27 |
| 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 | MR BARRY BRAINARD |
| Manufacturer Street | 6640 ELI WHITNEY DR. |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal | 21046 |
| Manufacturer Phone | 8034870493 |
| Manufacturer G1 | ACELL, INC. |
| Manufacturer Street | 6640 ELI WHITNEY DR. |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21046 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROMATRIX |
| Generic Name | MICROMATRIX |
| Product Code | KGN |
| Date Received | 2017-07-27 |
| Model Number | MM0030 |
| Lot Number | 008397 |
| Device Expiration Date | 2019-03-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACELL, INC. |
| Manufacturer Address | 6640 ELI WHITNEY DR COLUMBIA MD 21046 US 21046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-27 |