FDA Adverse Event
Malfunction
Summary report: N
MALIBU/SOVEREIGN (INCL. DIGNITY)
MDR report key: 3221051
·
Received July 5, 2013
Report
- Report Number
- 1419652-2013-00188
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 28, 2013
- Report Date
- June 28, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILM
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO ARJOHUNTLEIGH THAT THE RESIDENT WAS CUT WHEN THE BATH CHAIR SEAT BECAME DISLODGED. REF MFR REPORT 9611530-2013-00080.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307398 | MALIBU/SOVEREIGN (INCL. DIGNITY) | * | ILM | ARJO HOSPITAL EQUIPMENT AB | AZR33116-GB | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |