FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 26
MDR report key: 1883330
·
Received October 20, 2010
Report
- Report Number
- 1831750-2010-03089
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- September 23, 2010
- Report Date
- September 23, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA SERVICE REPORT THAT THE WELD BROKE AT THE LATCHING SPINDLE. THE USER FACILITY WAS UNABLE TO PROVIDE ANY INFO AS TO WHETHER THERE WAS PT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTAGE SERIES 26 | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP., MEDICAL DIVISION | 1001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |