FDA Adverse Event
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3230140
·
Received July 16, 2013
Report
- Report Number
- 1531186-2013-03186
- Date Received
- July 16, 2013
- Report Date
- June 25, 2013
- Manufacturer
- TAIWAN ANI CO., LTD.
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE IN88AHANFRFF MANUAL WHEELCHAIR HARDWARE HAS COME LOOSE AND CAUSED DAMAGE TO THE HEAD TUBE. FURTHER, THE REPORTER ALLEGED, THE PATIENT HAS ATTEMPTED TO FIX THE CHAIR ON HIS OWN; HOWEVER, THE PATIENT'S EFFORTS HAVE CAUSED FURTHER DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328809 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | TAIWAN ANI CO., LTD. | IN88AHANFRFF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |