D
Patient 1
THE NURSE REPORTED THAT THE NEEDLE HOLDER JOINT FELL APART DURING A BREAST AUGMENTATION AND THE SCREW FELL INTO THE PT. THE SCREW WAS RETRIEVED AND THE PT WAS NOT INJURED.
MAUDE MDR 354739
- MDR report key
- 354739
- Report number
- 1038548-2001-00032
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-09-04
- Date received
- 2001-10-05
- 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
- KRISTEN PIATAK
- Address
- 5175 S. ROYAL ATLANTA DR TUCKER GA 30096 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 | OLSEN HEGAR NEEDLE HOLDER | NEEDLE HOLDER | GENZYME BIOSURGERY A DIV OF GER | FHQ | NA | 32-0170 | UNK | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-10-05 | 0 |