FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3123240
·
Received May 21, 2013
Report
- Report Number
- 1525712-2013-04023
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Report Date
- February 11, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
INVACARE AWARENESS DATE IS (B)(4) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.
Description of Event or Problem · 1
THE DEALER REPORTED THAT THE SEAT ON THE ROLLATOR IS BROKEN. THIS ISSUE COULD CAUSE PRODUCT INSTABILITY AND THE ABILITY FOR THE SEAT TO MAINTAIN ITS WEIGHT BEARING CAPACITY, CAUSING THE USER TO FALL AND BE INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224436 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |