FDA Adverse Event
Injury
Summary report: N
PRIME ZOOM STRETCHER, 30"LITTER
MDR report key: 2120475
·
Received June 5, 2011
Report
- Report Number
- 1831750-2011-04326
- Event Type
- Injury
- Date Received
- June 5, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- PMA / PMN Number
- K022309
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN A STRYKER MEDICAL REPRESENTATIVE MET WITH THE USER FACILITY REPRESENTATIVE TO OBTAIN DETAILS OF THREE REPORTED CAREGIVER INJURY EVENTS, THEY REPORTED THAT THEY WERE UNABLE TO RETRIEVE THE INFORMATION ON THIS PARTICULAR EVENT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY TO THE SALES REPRESENTATIVE THERE WAS AN ALLEGED CAREGIVER INJURY WHILE ENGAGING THE BRAKES ON THE STRETCHER. HOWEVER, UPON FURTHER QUESTIONING THE USER FACILITY, THEY HAD NO INTERNAL REPORT REGARDING THE NATURE/DETAILS OF THIS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIME ZOOM STRETCHER, 30"LITTER | WHEELED POWERED STRETCHER | INK | STRYKER MEDICAL | 112500030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |