MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-15 for COPIOS MEMBRANE 97004 manufactured by Tutogen Medical Gmbh.
[138939317]
No unique donor or serial numbers were provided in order to conduct a manufacturing records re-review.
Patient Sequence No: 1, Text Type: N, H10
[138939318]
Doctor indicated non-integration of membrane and the event date was reported as (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2019-00001 |
| MDR Report Key | 8425037 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-15 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-15 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHARITY EMMONS |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3864188888 |
| Manufacturer G1 | RTI SURGICAL INC |
| Manufacturer Street | 11621 RESERACH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPIOS MEMBRANE |
| Generic Name | COPIOS PERICARDIUM MEMBRANE |
| Product Code | NPL |
| Date Received | 2019-03-15 |
| Catalog Number | 97004 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 6 NEUNKIRCHEN AM BRAND, GERMANY 91077 GM 91077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |