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 2020-03-16 for TUTOMESH? manufactured by Tutogen Medical, Gmbh.
[188688082]
Unique identifiers were not provided in order to conduct a comprehensive records re-review. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188688143]
Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020. An adverse event was reported through a post market survey for tutomesh? For breast reconstruction application via qualtrics survey software. The doctor indicated that in her four years of experience using the product, more than 10% have developed post-operative seromas, more than 5-10% of the cases/patients have experienced post radiation capsular contraction and radiation induced fibrosis, less than 1% have experienced implant loss and skin flap necrosis. To date, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2020-00013 |
| MDR Report Key | 9837005 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4188888436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUTOMESH? |
| Generic Name | BOVINE PERICARDIUM MEMBRANE |
| Product Code | FTM |
| Date Received | 2020-03-16 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL, GMBH |
| Manufacturer Address | INDUSTRIESTRABE 6 NEUNKIRCHEN AM BRAND 97077 GM 97077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |