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 2018-08-31 for BOVINE PERICARDIUM MEMBRANE 97002 manufactured by Tutogen Medical Gmbh.
[118910465]
A comprehensive re-review is being conducted of the manufacturing records, sterilization run reports, quality control/assurance reviews and release, and complaint database for related complaints for the lot. Once results are available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[118910466]
Rti surgical, inc (rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a complaint on 08/02/2018. The reported complaint indicated that the doctor noted loss of integration of a copios cancellous particules xenograft (graft not distributed in the usa) and a copios pericardium membrane. Both grafts were explanted. Additional information has been requested. To date, rti has not received any additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2018-00006 |
| MDR Report Key | 7837358 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-08-31 |
| 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 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 | BOVINE PERICARDIUM MEMBRANE |
| Generic Name | DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-08-31 |
| Catalog Number | 97002 |
| Lot Number | NZ16300031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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, 91077 GM 91077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-31 |