FDA Adverse Event
Other
Summary report: N
IN TOUCH ZU
MDR report key: 1714361
·
Received May 19, 2010
Report
- Report Number
- 9680128-2010-00039
- Event Type
- Other
- Date Received
- May 19, 2010
- Date of Event
- August 13, 2009
- Report Date
- April 26, 2010
- Manufacturer
- STRYKER MEDICAL QUEBEC LP
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL CUSTOMER'S BEDS HAVE BEEN VERIFIED TO BE IN PROPER WORKING ORDER BY THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THROUGH "NOTICE OF BREACH OF WARRANTY" THAT THE CLAIMANT WAS TAKING A PT FOR A PROCEDURE. REPORTEDLY, WHEN EXITING THE ELEVATOR, THE BED "KICKED FORWARD, PINNING [THE CLAIMANT] BETWEEN THE BED AND THE ELEVATOR DOOR." REPORTEDLY, THE CLAIMANT SUSTAINED INJURIES TO HER PELVIS AND BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZU | HOSPITAL BED, A-C POWERED, ADJUSTABLE | FNL | STRYKER MEDICAL QUEBEC LP | 2141000000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |