FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 29
MDR report key: 1850032
·
Received September 27, 2010
Report
- Report Number
- 1831750-2010-02580
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE WELD ON THE PATIENT RIGHT HAND SIDERAIL AT THE FOOT END WHERE THE SECOND SPINDLE ATTACHES TO THE LITTER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTAGE SERIES 29 | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP. MEDICAL DIVISION | 1501 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |