D
Patient 1
THE TIP BROKE WHILE CUTTING SOFT TISSUE DURING TRAM RECONSTRUCTION. THE PIECE THAT BROKE OFF WAS NOT FOUND. NO PT INJURY OR TREATMENT WAS REPORTED.
MAUDE MDR 305970
- MDR report key
- 305970
- Report number
- 1038548-2000-00029
- Event key
- 0
- Event type
- 3
- Date of event
- 2000-10-10
- Date received
- 2000-11-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- PETE STEGAGNO
- Address
- 5175 S. ROYAL ATLANTA DR TUCKER GA 30084 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REES FACELIFT SCS, SERR 6 3/4" | SCISSORS | GENZYME SURGICAL PRODUCTS | LRW | NA | 32-5822 | UNK | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-11-20 | 0 |