FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 2140830
·
Received May 31, 2011
Report
- Report Number
- 1831750-2011-05290
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
LOOSE LABEL WITH SHARP EDGES, DUE TO STICKY BACKING GIVING OUT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOTBOARD HAS A LABEL WITH A SHARP EDGE. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
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 |