D
Patient 1
REPORTER STATED, THE PRODUCT SLIPS WITH THE PT IN THE HOLDER. NO INJURY TO THE PT.
MAUDE MDR 1461433
- MDR report key
- 1461433
- Report number
- 3004608878-2009-00023
- Event key
- 0
- Event type
- 3
- Date received
- 2009-05-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- SHANNON DAVID
- Address
- 315 ENTERPRISE DR. PLAINSBORO NJ 08536 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD SWIVEL HORSESHOE HEADREST | NA | HBM | A1012 | 977 | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-05-18 | 0 |
Event Narratives#
N
Patient 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.