FDA Adverse Event
Other
Summary report: N
TREATMENT RECLINER
MDR report key: 2584600
·
Received May 15, 2012
Report
- Report Number
- 1831750-2012-05234
- Event Type
- Other
- Date Received
- May 15, 2012
- Date of Event
- March 19, 2012
- Report Date
- April 17, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FRK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: TRAINED STAFF ON USE OF DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HOSPITAL HAD LIGHTER PTS THAT WERE ALLEGEDLY BEING "POPPED OUT" OF THE RECLINERS WHEN USING THE RELEASE MECHANISM. IT WAS ALSO REPORTED THAT THE SALES REP VISITED THE FACILITY AND INVESTIGATED THE CONCERN AND DETERMINED THE TREND FOOT SWITCH WAS BEING IMPROPERLY USED BY THE STAFF AND THAT THE PT SAFETY TEAM LEADER AND NURSING STAFF HAVE NOW BEEN FULLY INSERVICED ON THE PROPER USE OF THE CHAIRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREATMENT RECLINER | RECLINER | FRK | STRYKER MEDICAL | 3500000710 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |