FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICE
MDR report key: 6206538
·
Received May 6, 2013
Report
- Report Number
- 1000282279-2013-00020
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Report Date
- May 8, 2013
- Manufacturer
- FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FROM IMPORTER'S MDR: 01/14/2013, RBS - THE DEALER REPORTED THAT THE UNK MODEL AND SERIAL NUMBER COMMODE WAS CRACKED. THERE WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198154 | DAILY ACTIVITY ASSIST DEVICE | COMMODE | ILS | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |