FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 4130022
·
Received September 30, 2014
Report
- Report Number
- 9615290-2014-00128
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Report Date
- September 11, 2014
- Manufacturer
- DOLOMITE AB
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER DEALER RIGHT HAND BRAKE NOT HOLDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608783 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | DOLOMITE AB | JAZZSTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |