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 2018-02-22 for BOVINE PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[100761121]
Product identifiers have not been provided at this time. Rti/tmi will conduct an investigation of hte product history for bovine pericardium membranes, packaging production records, environmental monitoring and distribution information for related complaint associated with the lot, once the unique identifiers are provided.
Patient Sequence No: 1, Text Type: N, H10
[100761122]
Rti surgical, inc (rti) and tutogen medical(b)(4)a wholly owned subsidiary of rti, received a complaint on (b)(6) 2018. The complaint indicated that a patient was implanted with a bovine pericardium membrane on (b)(6) 2017 and later developed skin symptoms that pointed towards an allergic reaction (unknown date of onset). On (b)(6) 2018, the complaint coordinator for the distributor called the allergist that evaluated the patient, who indicated that the bovine pericardium did not cause the allergic reaction. Product identifiers were not provided. Additional information was requested. To date, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2018-00001 |
| MDR Report Key | 7290445 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-02-22 |
| Date of Report | 2019-01-18 |
| Date Mfgr Received | 2018-01-26 |
| Date Added to Maude | 2018-02-22 |
| 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 | BOVINE PERICARDIUM MEMBRANE |
| Generic Name | DENTAL PERICARDIUM MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-02-22 |
| Lot Number | NOT PROVIDED |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTR 6 NEUNKIRCHEN, GERMANY 91077 GM 91077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-22 |