FDA Adverse Event
Malfunction
Summary report: N
FIXED DURAGUARD, 25MM"
MDR report key: 2223233
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-03009
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 22, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED ONCE ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN, THE PRODUCT WAS GETTING OVER-HEATED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXED DURAGUARD, 25MM" | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |