FDA Adverse Event
Malfunction
Summary report: N
HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753
MDR report key: 4344449
·
Received December 19, 2014
Report
- Report Number
- 1531186-2014-06488
- Event Type
- Malfunction
- Date Received
- December 19, 2014
- Report Date
- November 25, 2014
- Manufacturer
- JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATES, THE SEAT IS TEARING [PRID 210345] AND THE HAND BREAK IS NOT WORKING AND IS BENT. [PRID 235378]. WARRANTY RETURN PROCESSED FOR SEAT UPHOLSTERY 1149924 AND HAND BRAKE 1149223.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836498 | HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753 | WHEELCHAIR, MECHANICAL | IOR | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD | TRHD22FR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |