FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3171358
·
Received June 14, 2013
Report
- Report Number
- 1531186-2013-02625
- Date Received
- June 14, 2013
- Report Date
- May 20, 2013
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IKX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT HIT HER SIDE AND BACK AND NEEDED THE RESCUE SQUAD TO HELP GET HER UP. SHE STATES SHE IS BRUISED.
Description of Event or Problem · 1
A BATH BENCH W/O BACK THAT COLLAPSED WHILE IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271256 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | PINGHU WEIFENG MATERIAL TECHNOLOGY | 91-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |