MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-11-22 for COPIOS PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
| Report Number | 3002924436-2019-00011 |
| MDR Report Key | 9364705 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date Mfgr Received | 2019-10-22 |
| Date Added to Maude | 2019-11-22 |
| 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 | MRS LEILA KELLY |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3864188888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPIOS PERICARDIUM MEMBRANE |
| Generic Name | BOVINE PERICARDIUM MEMBRANE |
| Product Code | NPL |
| Date Received | 2019-11-22 |
| Lot Number | NZ18450194 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTRABE 6 NEUNKIRCHEN AM BRAND 91077 GM 91077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-22 |