N
Patient 1
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.
MAUDE MDR 9788452
- MDR report key
- 9788452
- Report number
- 3002924436-2020-00009
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS LEILA KELLY
- Address
- 11621 RESEARCH CIRCLE ALACHUA, FL US
- Phone
- 418-418-4188
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TUTOPATCH? DURAL SUBSTITUTE | DURAL GRAFT SUBSTITUTE | TUTOGEN MEDICAL GMBH | GXQ | NOT PROVIDED | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-04 | 0 | 1. O |
Event Narratives#
D
Patient 1
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 THE DOCTOR INDICATED THAT DURING HIS 15 YEARS OF USING THE PRODUCT, < 1% OF HIS PATIENTS/CASES HAVE EXPERIENCED INFECTION, INFLAMMATION AND BRAIN ABSCESS FORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.