FDA Adverse Event
Injury
Summary report: N
DAILY ACTIVITY ASSIST DEVICE
MDR report key: 6206511
·
Received June 14, 2013
Report
- Report Number
- 1000282279-2013-00033
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- June 9, 2012
- Report Date
- June 13, 2013
- Manufacturer
- FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
- Product Code
- ILS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AS PER IMPORTER'S MDR: ON (B)(6) 2012 - RBS, IT WAS REPORTED BY THE CONSUMER THAT BY OUR LEGAL DEPARTMENT RECEIVED A LETTER FROM AN ATTORNEY ON BEHALF OF A PT OF AN UNK MODEL AND SERIAL NUMBER SHOWER CHAIR, WHICH ALLEGEDLY HAS COLLAPSED DURING USE, RESULTING IN UNSPECIFIED INJURIES. SHOULD WE RECEIVE ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO REFLECT IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272465 | DAILY ACTIVITY ASSIST DEVICE | SHOWER CHAIR | ILS | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |