D
Patient 1
CUSTOMER INDICATED THAT THE SPRINGS ARE COMING OUT AND THE AREA WHERE THE NODE THAT KEEPS THE SCALPEL IN PLACE IS COMING APART.
MAUDE MDR 649654
- MDR report key
- 649654
- Report number
- 1832816-2005-00037
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-11-04
- Date received
- 2005-12-01
- 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
- BRUCE MACFARLANE
- Address
- 5182 W 76TH STREET EDINA MN 55439 US
- Phone
- 952-952-9526
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FUTURA SAFETY SCALPEL | SAFETY SCALPEL | FUTURA MEDICAL PRODUCTS(P) LTD. | GDX | 68001 | 68001 | UNK | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-12-01 | 0 |