FDA Adverse Event
Malfunction
Summary report: N
4.0MM TOMCAT CUTTER, FORMULA (5BX)
MDR report key: 1051326
·
Received May 22, 2008
Report
- Report Number
- 2648666-2008-00062
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 14, 2008
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SALES REP THAT THE TOMCAT SHAVER BLADE, U-SHAPED METAL HOUSING CAME OFF THE TOMCAT SHAVER BLADE INSIDE PT. WAS TAKEN OUT. FIRST TIME USING SHAVER BLADE. DID NOT USE OTHER BLADES FROM THE BOX AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM TOMCAT CUTTER, FORMULA (5BX) | CUTTER | HRX | STRYKER ENDOSCOPY PUERTO RICO | 08072CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |