FDA Adverse Event
Malfunction
Summary report: N
ROLLATOR JR RED 9153641188
MDR report key: 5153577
·
Received October 15, 2015
Report
- Report Number
- 9615290-2015-00296
- Event Type
- Malfunction
- Date Received
- October 15, 2015
- Date of Event
- September 22, 2015
- Report Date
- September 22, 2015
- Manufacturer
- DOLOMITE AB
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
BRAKE HANDLE KEEPS POPPING UP, WILL NOT HOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685504 | ROLLATOR JR RED 9153641188 | WALKER, MECHANICAL | ITJ | DOLOMITE AB | JAZZLOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |