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 2020-03-04 for TUTOPATCH? DURAL SUBSTITUTE manufactured by Tutogen Medical Gmbh.
[188687667]
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
[188687668]
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 tutopatch? For dura substitution application via qualtrics survey software. The doctor indicated that in his 10 years of experience using the product, 5-10% of his patients/cases have experienced adhesions, csf fistulas, meningitis and subdural empyema; and 1-5% have experienced infection, csf leaks, granuloma and slow resorption. Additional information has been requested. To date, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2020-00011 |
| MDR Report Key | 9788797 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | TUTOPATCH? DURAL SUBSTITUTE |
| Generic Name | DURAL GRAFT SUBSTITUTE |
| Product Code | GXQ |
| Date Received | 2020-03-04 |
| 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 | 2020-03-04 |