FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2143195
·
Received June 28, 2011
Report
- Report Number
- 1525712-2011-00302
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- May 31, 2011
- Manufacturer
- INVACARE
- Product Code
- IKX
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. ALLEGEDLY, THE CONSUMER WAS SITTING ON THE SHOWER CHAIR IN THE SHOWER WHEN THE CHAIR COLLAPSED FROM UNDER HER. THE CONSUMER IS A (B)(6) FEMALE WHO WEIGHTS (B)(6). THE CONSUMERS MEDICAL CONDITION AND STABILITY FOR USING THE SHOWER CHAIR ARE UNKNOWN. THE CONSUMERS MEDICATION REGIMEN IS UNKNOWN. THE ENVIRONMENTAL CONDITIONS SUCH AS LIGHTING, WETNESS, SLIPPERINESS OR SOAPINESS ARE UNKNOWN. MAINTENANCE HISTORY ON THE SHOWER CHAIR AND WEAR ON THE FOOTPADS ARE UNKNOWN. MDR FILED.
Description of Event or Problem · 1
THE CONSUMER WAS SITTING ON THE SHOWER CHAIR IN THE SHOWER, WHEN THE CHAIR ALLEGEDLY COLLAPSED FROM UNDER HER. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | INVACARE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 98 |