FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2895821
·
Received January 3, 2013
Report
- Report Number
- 1531186-2013-00034
- Date Received
- January 3, 2013
- Report Date
- January 3, 2013
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 1531186-2013-00034. END USER STATED DURING A FOLLOW UP CALL THAT THE SHOWER CHAIR IS NOT AN INVACARE PRODUCT. THE DEALER REFERRED HER TO INVACARE TO OBTAIN A SHOWER CHAIR FOR HER NEEDS. NON REPORTABLE EVENT - NOT AN INVACARE PRODUCT.
Description of Event or Problem · 1
CONSUMER STATED THE SEAT IS CRACKING FROM THE MIDDLE FRONT TO FRONT RIGHT LEG. THE END USER WILL BE ISSUED A SHOWER CHAIR WITH A WEIGHT CAPACITY OF 400. THIS UNIT HAS A WEIGHT CAPACITY OF 315 LBS. THE END USER WAS NOT HARMED OR INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3078 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | PINGHU WEIFENG MATERIAL TECHNOLOGY | 96-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |