MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-06 for MATRISTEM MICROMATRIX MM manufactured by Acell, Inc.
[56757851]
Acell is continuing to work with the physician to collect additional facts surrounding this report.
Patient Sequence No: 1, Text Type: N, H10
[56757852]
Acell received a report from a physician that a patient developed rashes after micromatrix reconstituted by the physician with saline and lidocaine was injected into the scalp, neck, and chest. According to the physician, the patient had undergone the same procedure 2 or 3 times without any issues. Three days after the most recent procedure, the patient allegedly developed rashes. Patient has been treated with topical steroidal cream, medrol, and prednisone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2016-00005 |
| MDR Report Key | 6004433 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-06 |
| Date of Report | 2016-09-06 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-06 |
| Date Added to Maude | 2016-10-06 |
| 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 | 2016-10-06 |
| Model Number | MM |
| 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. Required No Informationntervention | 2016-10-06 |