N
Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9800241
- MDR report key
- 9800241
- Report number
- 0001526350-2020-00257
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CHRISTINA ARNT
- Address
- 56 E. BELL DRIVE WARSAW IN 46582 US
- Phone
- 574-574-5745
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZIMMER SKIN GRAFT MESHER | EXPANDER, SURGICAL, SKIN GRAFT | ZIMMER SURGICAL, INC. | FZW | 00770100000 | NI | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-06 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE DEVICE DIDN'T MESH. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.