FDA Adverse Event Injury Summary report: N

DRIVE

MDR report key: 2892724 · Received December 26, 2012

Report

Report Number
MW5028355
Event Type
Injury
Date Received
December 26, 2012
Date of Event
December 8, 2012
Report Date
December 11, 2012
Manufacturer
MEDICAL DEPOT, INC. DBA DRIVE MEDICAL DESIGN AND MANUFACTURING
Product Code
ITJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

PRODUCT IS A 1 YEAR-OLD ALUMINUM 4-WHEEL ROLLATOR WITH UNIVERSAL SEAT HEIGHT; THE SEAT IS INTENDED TO BE SAT UPON. MY (B)(6) GREAT AUNT, WHO LIVES ALONE, WAS USING THE ROLLATOR AS A WALKER IN HER KITCHEN WHEN THE ALUMINUM FRAME (THE ACTUAL METAL) SUPPORTING THE BACK RIGHT LEG UNEXPECTEDLY BROKE APART, (THE METAL FAILED / FRACTURED), CAUSING HER TO LOSE HER BALANCE. AS SHE WAS STANDING WHEN THE EVENT OCCURRED, SHE WAS ABLE TO GRAB HER KITCHEN TABLE AND PREVENT SIGNIFICANT INJURY. HAD SHE BEEN WALKING IN AN AREA OF THE APARTMENT WHERE THERE IS NOTHING TO GRAB, SHE WOULD HAVE FALLEN AND BEEN SEVERELY INJURED. HAD SHE BEEN SITTING ON THE SEAT WHEN THE LEG FAILED, SHE WOULD HAVE FALLEN AND BEEN SEVERELY INJURED. THE PRODUCT HAS NEVER BEEN MISHANDLED, MISUSED OR DROPPED AND IS PRIMARILY USED INDOORS. (IT IS FOLDED AND TRANSPORTED IN THE BACK OF AN SUV FOR THE PURPOSE OF BEING USED TO ATTEND DOCTOR'S APPOINTMENTS AND CHURCH.) THE ROLLATOR HAS NEVER BEEN USED BY ANYONE OTHER THAN THE (B)(6) FEMALE. LABELING ON THE DEVICE INDICATES THAT THE WEIGHT LIMIT FOR THE SEAT IS 300 POUNDS. THE (B)(6) FEMALE USING THE DEVICE IS WELL BELOW THAT LIMIT AT APPROXIMATELY (B)(6). WITH REGARDS TO THE INCIDENT BEING REPORTED, I AM IN POSSESSION OF THE BROKEN MEDICAL DEVICE AND OF PHOTOGRAPHS OF THE FAILURE AND LABELING. ALL FOUR LEGS WERE SET AT THE SAME HEIGHT SETTING, 22", BY THE RETAILER, WHO IS AN AUTHORIZED DISTRIBUTOR. DATE OF USE: APPROXIMATELY (B)(6) 2011 TO (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: ARTHRITIS, STABILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DRIVE ROLLATOR 4 WHEEL ITJ MEDICAL DEPOT, INC. DBA DRIVE MEDICAL DESIGN AND MANUFACTURING RTL10261RD NA

Patients

Seq Age Sex Outcome Treatment
1 91 YR Required Intervention