FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 29 P-WASH
MDR report key: 1964000
·
Received January 12, 2011
Report
- Report Number
- 1831750-2011-00358
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIV.
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
BRACKET.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PT LEFT FORWARD BRACKET WELD FOR THE SIDERAIL IS CRACKED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENAISSANCE 29 P-WASH | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP, MEDICAL DIV. | 1731 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |