FDA Adverse Event
Injury
Summary report: N
FORMULA SHAVER HANDPIECE (WITH BUTTONS)
MDR report key: 1991580
·
Received February 7, 2011
Report
- Report Number
- 2936485-2011-00076
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- HRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. A SIMILAR PRODUCT WITH SERIAL NUMBER (B)(4) WAS ALSO IMPLICATED IN THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT 2 DIFFERENT UNITS MALFUNCTIONED DURING SURGERY. ONE UNIT FAILED TO RECOGNIZE THE BLADE. THE OTHER UNIT SHOCKED THE DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORMULA SHAVER HANDPIECE (WITH BUTTONS) | SHAVER | HRX | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |