FDA Adverse Event
Injury
Summary report: N
5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
MDR report key: 2233948
·
Received August 30, 2011
Report
- Report Number
- 2648666-2011-00210
- Event Type
- Injury
- Date Received
- August 30, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 4, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, THE UNIT WAS BEING USED FOR LONG PERIOD OF TIME. IT APPEARED THAT THE HANDPIECE WAS HEATING UP, HOWEVER, THIS WAS NOT NOTICEABLE TO THE PHYSICIAN. IT APPEARED THAT THE UNIT'S EJECT BUTTON WAS LYING ON THE PT RESULTING IN A BURN JUST INSIDE THE INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX) | BUR | HTT | STRYKER ENDOSCOPY PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |