D
Patient 1
DURING VEIN STRIPPING/LIGATION, THE VEIN STRIPPER MALFUNCTIONED DUE TO "STRIPPED THREADS ON THE WIRE CAUSING THE SCREW-ON TIP TO BE LIBERATED IN THE LEFT GREATER SAPHENOUS VEIN. SURGEON ABLE TO REMOVE IT THROUGH AN ADDITIONAL INCISION.
MAUDE MDR 336210
- MDR report key
- 336210
- Report number
- 6000008-2001-00006
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-01-22
- Date received
- 2001-06-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- * * *
- Phone
- **
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NABATOFF VEIN STRIPPER | INSTRUMENT | ALLEGIANCE HEALTHCARE - DISTRIBUTION | GAI | SU11770 | SU11770 | UNK | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-06-06 | 0 | 1. O; 2. R |