FDA Adverse Event
Injury
Summary report: N
5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
MDR report key: 2032658
·
Received March 16, 2011
Report
- Report Number
- 2648666-2011-00075
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 4, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON WAS CONCERNED WITH THE HEAT COMING FROM THE SHEATH OF THE UNIT AFTER THE UNIT CAUSED BURNS DURING A DECOMPRESSION. IT WAS FURTHER REPORTED THAT THE UNIT WAS DISCARDED.
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 | Other | DF |