FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2082789
·
Received April 29, 2011
Report
- Report Number
- 1525712-2011-00178
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 19, 2011
- Report Date
- April 28, 2011
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CONSUMER ALLEGES THE LEFT FRONT LEG SNAPPED, CAUSING HIM TO FALL. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN / IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. NO SERIOUS INJURY IS REPORTED. MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.
Description of Event or Problem · 1
THE FRONT LEFT LEG ALLEGEDLY SNAPPED, CAUSING THE CONSUMER TO FALL AND HIT HIS HEAD AND ELBOW. NO SERIOUS INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL HOMECARE PRODUCTS | 65100 | GT090608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |