FDA Adverse Event
Malfunction
Summary report: N
CAST CUTTER, 8 FOOT CORD"
MDR report key: 2213802
·
Received August 4, 2011
Report
- Report Number
- 1811755-2011-02794
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 15, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HAB
- PMA / PMN Number
- PRE-AMEN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A F/U REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING PRIOR TO THE START OF A PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAST CUTTER, 8 FOOT CORD" | HAB | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |