FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 29 P-WASH
MDR report key: 2182043
·
Received June 22, 2011
Report
- Report Number
- 1831750-2011-06343
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULT: BUMPER CHANNEL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BUMPER CHANNEL WAS HANGING OFF OF THE STRETCHER AND IT WAS SHARP. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENAISSANCE 29 P-WASH | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1731 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |