FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2399097
·
Received January 5, 2012
Report
- Report Number
- 1525712-2012-00034
- Date Received
- January 5, 2012
- Report Date
- January 5, 2012
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(6) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL (B)(4) DETERMINED THIS IS AN MDR.
Description of Event or Problem · 1
THE CONSUMER WAS SITTING ON THE 91-2 SHOWER CHAIR, WHEN THE LEG ALLEGEDLY BENT, CAUSING THE CONSUMER TO FALL. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | PINGHU WEIFENG MATERIAL TECHNOLOGY | 91-2 | PW091015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |