MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-10 for COPIOS PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[74828344]
Rti/tmi will conduct a re-review of the product history record for copios pericardium membranes, packaging production records, environmental monitoring, distribution for related complaints associated to the lot. A follow-up med watch will be submitted. Implanted not available for return.
Patient Sequence No: 1, Text Type: N, H10
[74828345]
It was reported that on (b)(6) 2016 a puros pi block and cancellous particulates and a copios pericardium membrane was implanted for a dental procedure with the follow up treatment he noticed dehiscence of suture in the grafted area, even though there was no infection. The block is still in its place but he wanted to report the delayed wound healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2017-00010 |
| MDR Report Key | 6556853 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-10 |
| Date of Report | 2017-08-08 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-05-10 |
| 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 | MS. CHARITY |
| 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 RESEARCH 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 PERICARDIUM MEMBRANE |
| Generic Name | PERICARDIUM MEMBRANE , PRODUCT CODE NPL |
| Product Code | NPL |
| Date Received | 2017-05-10 |
| Lot Number | NZ15160015 |
| Operator | DENTIST |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTR. 6 NEUNKIRCHEN, GERMANY 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-10 |