FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 2142602
·
Received June 21, 2011
Report
- Report Number
- 1525712-2011-00286
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 24, 2011
- Report Date
- June 20, 2011
- Manufacturer
- UNKNOWN
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. ALLEGEDLY, THE LIFT LOCKED UP AND THE CONSUMER FELL FROM THE SLING. ALLEGEDLY, THE CONSUMER'S MOTHER WAS TRYING TO HOLD THE LIFT UP TO GET HER SON BACK INTO BED AND HURT HER LEG. THE LIFT IS CURRENTLY STILL LOCKED UP. THE DEALER WAS CALLED TO SERVICE THE LIFT BECAUSE THE HYDRAULIC PUMP WAS "DEFLATING." THE CONSUMER IS A (B)(6).
Description of Event or Problem · 1
THE LIFT ALLEGEDLY LOCKED UP AND THE CONSUMER FELL FROM THE SLING. THE CONSUMER'S MOTHER WAS ALLEGEDLY TRYING TO HOLD THE LIFT UP TO GET HER SON BACK INTO BED AND HURT HER LEG. THE LIFT IS CURRENTLY STILL LOCKED UP. THE DEALER WAS CALLED TO SERVICE THE LIFT BECAUSE THE HYDRAULIC PUMP WAS "DEFLATING." NO SERIOUS INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | FSA | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |