FDA Adverse Event
Injury
Summary report: N
FLEX-MATE K5OO ANATOMICAL KNEE CPM
MDR report key: 17525934
·
Received August 12, 2023
Report
- Report Number
- MW5132874
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- July 28, 2015
- Manufacturer
- KLC
- Product Code
- BXB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
FACILITY REPORTED ERROR MESSAGES. MACHINE LOCKED UP. REPLACEMENT ISSUED. (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 |
|---|---|---|---|---|---|---|---|
| 2218391 | FLEX-MATE K5OO ANATOMICAL KNEE CPM | EXERCISER, POWERED | BXB | KLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |