FDA Adverse Event
Malfunction
Summary report: N
WHEELCHAIR
MDR report key: 17488328
·
Received August 9, 2023
Report
- Report Number
- MW5121026
- Event Type
- Malfunction
- Date Received
- August 9, 2023
- Report Date
- December 4, 2022
- Manufacturer
- GF HEALTH PRODUCTS, INC
- Product Code
- IOR
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER EVEREST AND JENNINGS WHEELCHAIR, SERIAL NUMBER (B)(6) WITH REDUCED BRAKE FORCE AND BRAKES THAT CANNOT BE ENGAGED. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. (B)(6). (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1689219 | WHEELCHAIR | WHEELCHAIR, MECHANICAL | IOR | GF HEALTH PRODUCTS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |