FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 2111351
·
Received May 18, 2011
Report
- Report Number
- 1831750-2011-04851
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: CRACKED SIDERAIL WITH EXPOSED SHARP EDGES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD RIGHT SIDE RAIL HAD NO FUNCTION. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZU | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | 2141 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |