FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICE
MDR report key: 4944971
·
Received June 14, 2013
Report
- Report Number
- 1000282279-2013-00043
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Report Date
- June 13, 2013
- Manufacturer
- FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER IMPORTER'S MDR: 02/06/2013 - RBS - THE DEALER REPORTED THAT THE 6495 COMMODE ARM REST WAS BROKEN. THERE WAS NO PATIENT INJURY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272417 | DAILY ACTIVITY ASSIST DEVICE | ILS | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. | 6495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |