MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-22 for MICROMATRIX MM0100F manufactured by Acell, Inc..
| Report Number | 3005920706-2019-00018 |
| MDR Report Key | 9218567 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-22 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2019-10-22 |
| 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 | 4109538558 |
| 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 | 2019-10-22 |
| Model Number | MM0100F |
| Catalog Number | MM0100F |
| Lot Number | 017096 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-10-22 |