FDA Adverse Event
Other
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 1463363
·
Received August 31, 2009
Report
- Report Number
- 1831750-2009-00932
- Event Type
- Other
- Date Received
- August 31, 2009
- Date of Event
- September 19, 2007
- Report Date
- September 25, 2007
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- FPO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED BY A PATIENT THAT HE SAT ON THE SIDE OF THE STRETCHER (MIDDLE) IN LOW HEIGHT AND IT TILTED OVER. REPORTEDLY, THE PATIENT FELL ON THE FLOOR. A USER-FACILITY REPRESENTATIVE REPORTED THAT THE PATIENT WAS AN ELDERLY MAN WHO ALREADY HAD PROBLEMS WITH HIS BACK AND LEGS. ALLEGEDLY, THE PATIENT REQUIRED SURGERY WHICH MAY HAVE BEEN PARTIALLY DUE TO THE FALL. THE USER-FACILITY REPRESENTATIVE REPORTED THAT THEY BELIEVE THE PATIENT MISSED THE STRETCHER WHEN HE SAT DOWN. THE STRETCHER WAS EVALUATED BY THE HOSPITAL AND STRYKER FIELD SERVICE, AND NO PRODUCT PROBLEM WAS FOUND. THE USER-FACILITY REPRESENTATIVE SAID THAT HE SAT ON THE STRETCHER, AS THE PATIENT DESCRIBED AND THE STRETCHER REMAINED PERFECTLY...
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 MSERIES W5TH WHL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP, MEDICAL DIVISION | 1005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |