D
Patient 1
DURING BREAST AUGMENTATION SURGERY, PT WAS BURNED AT THE AREA JUST BELOW THE AREOLA. THE BURN AREA WAS EXCISED, AND WAS APPROXIMATELY 1 CM BY 1 CM. THE BURN WAS REPORTEDLY CAUSED BY A 2 MM VOID IN THE DEVICE INSULATION.
MAUDE MDR 315573
- MDR report key
- 315573
- Report number
- 2916288-2001-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-01-01
- Date received
- 2001-02-06
- 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
- CINDY FEUSTEL MANAGER
- Address
- 2100 MERIDIAN PARK BLVD CONCORD CA 94520 US
- Phone
- 925-925-9258
- 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 675 | ELECTRODE EXTENDER | OLSEN ELECTROSURGICAL | JOS | 675 | 675 | 100493 | K885200 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-02-06 | 0 | 1. O |