FDA Adverse Event
Injury
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 1798543
·
Received August 4, 2010
Report
- Report Number
- 1831750-2010-01709
- Event Type
- Injury
- Date Received
- August 4, 2010
- Date of Event
- July 6, 2010
- Report Date
- July 13, 2010
- Manufacturer
- STRYKER CORP., MED DIV
- Product Code
- FPO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICES WERE EVALUATED AND REPAIRED BY THE DISTRIBUTOR. EVAL CODES REFLECT THE DISTRIBUTOR'S FINDINGS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SIDE RAIL DROPPED DOWN WHEN THE PT LEANED ON IT. THE PT FELL OFF THE STRETCHER AND SUSTAINED INJURIES ALLEGEDLY BECAUSE THE LOCK ON THE SIDE RAILS DID NOT WORK PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP., MED DIV | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |