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 2016-10-27 for MATRISTEM MICROMATRIX MM0100F manufactured by Acell, Inc.
[58502112]
A comprehensive investigation was conducted on discovery. Treating physician was contacted and confirmed the complainant underwent a hair restoration procedure wherein a suspension of prp and micromatrix was injected into the scalp. The patient was treated with lidocaine injected into the scalp just prior to the procedure. Physician stated the patient had swelling at the injection site that lasted longer than normal. However, he believed the headaches are the patient's main issue. Additionally, patient stated she declined customary nsaids given at the completion of the procedure. Physician stated he has used acell micromatrix in the same manner for 5 years and has not had other patients who have experienced similar issues. According to the physician, the patient did not have any signs of infection on the scalp and did not develop a fever. The physician also stated that he has used the same lot of micromatrix on several other patients with no issues. He is working with the patient's primary care physician to determine a path forward. A review of the manufacturing records for the lot identified no substantial deviation and demonstrated the product was manufactured and distributed in compliance with fda, state, local, and manufacturer operating procedures. There was no report of device failure from the treating physician at any time. This mdr has been filed out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[58502113]
Acell received a report from a patient who claimed she developed swelling and headaches after micromatrix reconstituted with platelet rich plasma (prp) was injected into the scalp by her physician. The patient was also injected with lidocaine into the scalp just prior to the micromatrix suspension treatment. Four days later, the complainant alleged she developed swelling, severe headaches with dizziness, and a bulging vein. She stated swelling lasted for approximately 3 weeks and took a month to fully resolve. Patient claimed she has been in contact with the treating physician and her primary care physician to try to treat and eliminate the persistent headaches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2016-00006 |
| MDR Report Key | 6060035 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-10-27 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-09-30 |
| Device Manufacturer Date | 2016-03-22 |
| Date Added to Maude | 2016-10-27 |
| 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 | MATRISTEM MICROMATRIX |
| Generic Name | POWDER WOUND DRESSING |
| Product Code | KGN |
| Date Received | 2016-10-27 |
| Model Number | MM0100F |
| Lot Number | LP5917-11 |
| Device Expiration Date | 2018-03-31 |
| 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. Hospitalization; 2. Other | 2016-10-27 |