FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2821854
·
Received November 6, 2012
Report
- Report Number
- 1531186-2012-01355
- Date Received
- November 6, 2012
- Report Date
- November 6, 2012
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER RECEIVED A TRANSFER BENCH AND IT WORKED WELL FOR A FEW MONTHS. AFER A FEW MONTHS OF USE THE CUSTOMER NOTICED THE SEAT HAS BEGUN TO CRACK. THE CUSTOMER IS WELL WITHIN THE 315 POUND WEIGHT CAPACITY, AT (B)(6), AND IS USING THE BENCH AS DIRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | PINGHU WEIFENG MATERIAL TECHNOLOGY | 98071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 | Other |