FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3211991
·
Received July 8, 2013
Report
- Report Number
- 1525712-2013-05469
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Report Date
- June 13, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES THAT THE SEAT UPHOLSTERY IS RIPPING AT THE GROMMETS. THEY DO NOT HAVE THE UPHOLSTERY IN THEIR RECEIVING. THEY WILL CONTACT THE END USER TO GET UPHOLSTERY AND CALL BACK IN TO SET UP RMA. PART# IS CPTRV231. INVACARE SEAT UPHOLSTERY, 22 INCH WIDE X 18 INCH DEEP, EMBOSSED, MIDNIGHT BLUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309115 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |