FDA Adverse Event
Malfunction
Summary report: N
MOBILE TREAT. REC. LY5007
MDR report key: 2051366
·
Received April 4, 2011
Report
- Report Number
- 1831750-2011-03233
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 6, 2011
- Report Date
- March 7, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVAL: MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RECLINER MECHANISM IS BROKEN WITH SHARP EDGES PRESENT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOBILE TREAT. REC. LY5007 | MEDICAL CHAIR | FRK | STRYKER MEDICAL | 3300000020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |