D
Patient 1
THE COMPLAINANT ALLEGED THAT THE BLACK PLASTIC COVER, WHICH SITS ON THE END OF THE SCREW, BECAME DETACHED DURING AN OPERATION AND REQUIRED REMOVAL FROM THE PT WOUND.
MAUDE MDR 273616
- MDR report key
- 273616
- Report number
- 1038548-2000-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-08-25
- Date received
- 2000-04-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS LEIGH GAYLE, SPECIALIST
- 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 | SWITCHBLADE SCISSOR TIP | SCISSORS | GENZYME SURGICAL PRODUCTS CORP. | KNS | NA | 89-5100 | 249496 | K930666 | N | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-04-14 | 0 | 1. R |