FDA Adverse Event
Malfunction
Summary report: N
IMPACTION BUR GUARD
MDR report key: 1712980
·
Received August 31, 2009
Report
- Report Number
- 1811755-2009-00457
- Event Type
- Malfunction
- Date Received
- August 31, 2009
- Date of Event
- November 30, 2007
- Report Date
- November 30, 2007
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- K961970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF 08/21/2009, THE BUR GUARD HAS NOT BEEN RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE BUR GUARD HEATED UP AND CAUSED A MINOR MUCOSAL BURN. THE DOCTOR REPORTED THAT NO SCAR IS EXPECTED AND THEY HAVE ALREADY SEEN THE PT AGAIN; THE BURN HAS HEALED FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPACTION BUR GUARD | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | HWE | STRYKER INSTRUMENTS KALAMAZOO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |