FDA Adverse Event
Malfunction
Summary report: N
STRYKER CORPORATION
MDR report key: 119160
·
Received September 9, 1997
Report
- Report Number
- 1831750-1997-00014
- Event Type
- Malfunction
- Date Received
- September 9, 1997
- Date of Event
- August 13, 1997
- Report Date
- August 25, 1997
- Manufacturer
- *
- Product Code
- FPO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE RIGHT WHEEL CASTER BOLT BROKE IN HALF CAUSING THE WHEEL TO COME OFF AT THE HEAD OF THE STRETCHER. THE STRETCHER ROLLED OVER TO RIGHT SIDE LEANING THE PT INTO THE RIGHT SIDERAIL WHICH HAD BEEN IN THE UPRIGHT POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER CORPORATION | STRETCHER | FPO | * | UNK | PATENT # 3304116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |