MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-26 for BOVINE PERICARDIUM MEMBRANE 97002 manufactured by Tutogen Medical Gmbh.
[106600514]
Rti/tmi will conduct an investigation of the product history record for bovine pericardium membranes for the lot, including packaging production records, environmental monitoring, distribution information, related complaint associated to the lot.
Patient Sequence No: 1, Text Type: N, H10
[106600515]
It was reported that the patient underwent a dental procedure on (b)(6) 2014 and (b)(6) 2015, with implantation of bovine copios membrane, bovine copios particles and human spongiosa partikel. Dentist reported non-integration and persistent facial swelling and edema for months. Explantation date: (b)(6) 2017 (tooth location: 26).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2018-00003 |
| MDR Report Key | 7464256 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2014-09-11 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-04-26 |
| 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 |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 4864188888 |
| Manufacturer G1 | RTI SURGICAL |
| 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 | BOVINE PERICARDIUM MEMBRANE |
| Generic Name | DENTAL PERICARDIUM MEMBRANE, PRODUCT CODE NPL |
| Product Code | NPL |
| Date Received | 2018-04-26 |
| Catalog Number | 97002 |
| Lot Number | NZ14070183 |
| Device Availability | N |
| 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 | 2018-04-26 |