FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICE
MDR report key: 3232205
·
Received October 4, 2012
Report
- Report Number
- 1000282279-2012-00027
- Event Type
- Malfunction
- Date Received
- October 4, 2012
- Report Date
- October 4, 2012
- Manufacturer
- FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(B)(4) - THE DEALER STATED THAT THE CONSUMER ALLEGEDLY FELL TWICE WHILE HOLDING THE 710-4 GRAB BAR. THERE WAS NO INJURY REPORTED. REF (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICE | IKX | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. | 710-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |