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 2017-04-28 for COPIOS PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[73964731]
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. Explanted not available.
Patient Sequence No: 1, Text Type: N, H10
[73964732]
On (b)(6) 2016 the dentist implanted two copios pericardium membranes and two puros allograft blocks. On (b)(6) 2016 patient went for a checkup and swelling was noted and the wound was sealed. On (b)(6) "2012" at another checkup the patient was noted to have swelling and the wound was sealed. On (b)(6) 2016 the patient returned and wound dehiscence and reddening on both sides were noted the patient was rinsing with betaisodona. On (b)(6) 2016 the patient was noted to be rinsing with betaisodona. On (b)(6) 2016 the patient returned and symptoms noted were infection, reddening pain, inflammation, swelling, suture, dehiscence, soft tissue dehiscence, loss of transplant, bone block was not vascularized. The dentist attempted wound revision, explantation on both sides.
Patient Sequence No: 1, Text Type: D, B5
[119062848]
Conclusion noted on follow-up #1 stated there were no related complaints for the lot nz16200153, when in fact there are 4 related complaints for the lot. Of note the batch records review was perfomed on complaint lot. The review includes among others sterilization certificates and the microbiological controls and showed that for all products all specifications were met at the time of release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002924436-2017-00009 |
| MDR Report Key | 6530613 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-28 |
| Date of Report | 2017-07-17 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-04-28 |
| 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 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 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 | 2017-04-28 |
| Lot Number | NZ16200153 |
| 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, 91077GM G GM 91077GM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-28 |