FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4953548
·
Received September 30, 2013
Report
- Report Number
- 9612393-2013-00231
- Event Type
- Malfunction
- Date Received
- September 30, 2013
- Report Date
- September 30, 2013
- Manufacturer
- TAIWAN AN I CO.,LTD.
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO WAY TO KNOW WHETHER THIS DEVICE WAS MANUFACTURED BY (B)(4) INDUSTRIES LTD SINCE THERE WAS NO MODEL NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
PER IMPORTER'S MDR: PURCHASED LESS THAN 2 YEARS AGO. LACK OF DURABILITY AND POOR RESPONSE TIME ON GETTING REPLACEMENT PARTS. FOOT RESTS NEEDED REPLACED, REAR FOOT STRAP HAS BOLT MISSING, THE REAR WHEEL ALMOST FELL OFF AND NEEDED WHEEL BEARINGS REPLACED. MOST RECENTLY THE FRONT WHEEL BROKE OFF AND WE WERE STRANDED, THE STAFF AT PVH HAS TRIED TO GET A REPLACEMENT WHEEL FOR WEEKS AND STILL HAVE NO PARTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 494054 | MECHANICAL (MANUAL) WHEELCHAIR | WHEELCHAIR | IOR | TAIWAN AN I CO.,LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |