FDA Adverse Event
Malfunction
Summary report: N
ROLLATORS-615
MDR report key: 19348132
·
Received May 18, 2024
Report
- Report Number
- 3014644996-2024-00006
- Event Type
- Malfunction
- Date Received
- May 18, 2024
- Report Date
- May 18, 2024
- Manufacturer
- COM-DA HEALTHCARE CO.,LTD
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER HAS A ROLLATOR AND BOTH BRAKES ARE NOT WORKING PROPERLY. THE LEFT ONE IS COMPLETE BROKEN AND THE RIGHT ONE DOESN'T STOP CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642665 | ROLLATORS-615 | WALKER | ITJ | COM-DA HEALTHCARE CO.,LTD | 1-RLAJ6BL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Unknown |