FDA Adverse Event
Malfunction
Summary report: N
MOBILE TREAT. REC. LY5007
MDR report key: 2835733
·
Received October 12, 2012
Report
- Report Number
- 1831750-2012-10716
- Event Type
- Malfunction
- Date Received
- October 12, 2012
- Date of Event
- September 21, 2012
- Report Date
- September 21, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FRJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FRAME IS BROKEN ON SEAT WHERE BACKREST ATTACHES. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOBILE TREAT. REC. LY5007 | RECLINER | FRJ | STRYKER MEDICAL | 3300000020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |