FDA Adverse Event
Malfunction
Summary report: N
FLEXMATE K500
MDR report key: 17534837
·
Received August 12, 2023
Report
- Report Number
- MW5141736
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- August 10, 2015
- Manufacturer
- KLC, 4038 WEAVER COURT E., HILLIARD, OH 43026
- Product Code
- BXB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
POWER FAILURE. REPLACEMENT ISSUED. ITEM NUMBER: 023903 INVACARE PRID# (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 |
|---|---|---|---|---|---|---|---|
| 1085888 | FLEXMATE K500 | EXERCISER, POWERED | BXB | KLC, 4038 WEAVER COURT E., HILLIARD, OH 43026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |