FDA Adverse Event
Summary report: N
AESCULAP
MDR report key: 1832977
·
Received September 2, 2010
Report
- Report Number
- 1832977
- Date Received
- September 2, 2010
- Date of Event
- July 16, 2010
- Report Date
- August 31, 2010
- Manufacturer
- AESCULAP, INC.
- Product Code
- HSO
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A PATIENT UNDERWENT A LE FORT 1 OSTEOTOMY. DURING THE COMPLETION OF THE OSTEOTOMY, THE PROTECTED PORTION OF THE HANDPIECE MADE CONTACT WITH THE EXTRA ORAL PORTION OF THE LEFT UPPER LIP. ACCORDING TO THE SURGEON, THIS PORTION OF THE HANDPIECE WAS WARM. THE SURGEON FINISHED THE PROCEDURE WITHOUT ANY COMPLICATIONS. DURING THE POST OPERATIVE PERIOD, THE LIP WAS NOTED TO HAVE A SUPERFICIAL SECOND DEGREE BURN WHICH WAS TREATED WITH LOCAL WOUND CARE. THE DEVICE HEATED UP SHORTLY INTO THE PROCEDURE.IS EVENT HEALTH IT RELATED?NO
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AESCULAP | RECIPROCATING SAW HAND PIECE | HSO | AESCULAP, INC. | GB130R | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |