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 2016-05-18 for MATRISTEM MICROMATRIX MM0100 manufactured by Acell, Inc.
[45406257]
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 in the scalp. Physician stated the patient did not come in for any follow-up visits, but patient did call regarding forehead swelling and was instructed to put ice on the area and was advised that the swelling would subside in a few days. Physician stated he has extensive experience with micromatrix? In his personal practice, and he is very comfortable with the product and its safety profile for the particular application that he employs. He stated "i don't believe acell or my procedure was involved" in a potential adverse outcome. Additionally, the physician was concerned about the anesthetic possibly leading to an allergic response, particularly lidocaine. 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 attending physician at any time. This mdr has been filed out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[45406258]
Acell received a complaint from a patient who underwent administration of micromatrix? To the scalp via injection. The treating physician opted to treat this particular patient with lidocaine and marcaine prior to injecting the patient with a suspension of micromatrix? And platelet rich plasma (prp). Two days post procedure, the complainant alleged he developed swelling on his forehead, eyelids, nose and nose bridge. He stated he later became nauseous, had post nasal drip, swollen muscles, joint pain, swollen lymph nodes, easy bruising, altered smell, insomnia, anxiety, and tachycardia. Patient claimed he had subsequently been seen by a rheumatologist, ent, allergist, and has presented to an er where he was treated for his anxiety and tachycardia with zoloft as treatment.
Patient Sequence No: 1, Text Type: D, B5
[48356208]
This is a follow up report with updated information regarding testing conducted on a sister device from the same lot. A sister graft from the same lot was tested for sterility and results of no growth substantiated that the lot was supplied sterile.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005920706-2016-00004 |
| MDR Report Key | 5663248 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-05-18 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-04-18 |
| Device Manufacturer Date | 2016-02-11 |
| Date Added to Maude | 2016-05-18 |
| 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 | DRESSING, WOUND, COLLAGEN |
| Product Code | KGN |
| Date Received | 2016-05-18 |
| Model Number | MM0100 |
| Lot Number | LP5643-11 |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-05-18 |