FDA Adverse Event Malfunction Summary report: N

NOVA MIGHTY MACK ROLLATOR

MDR report key: 3087215 · Received April 26, 2013

Report

Report Number
MW5029982
Event Type
Malfunction
Date Received
April 26, 2013
Date of Event
April 17, 2013
Report Date
April 18, 2013
Manufacturer
NOVA ORTHO-MED INC.
Product Code
ITJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

PRODUCT IS NOVA MIGHTY MACK ROLLATOR MODEL 4216, S/N (B)(4) PURCHASED (B)(6) 2007, MANUFACTURED BY NOVA ORTHO-MED INC. PROBLEM IS THAT THE WELD AT THE BOTTOM OF THE FRONT FRAME TUBE WHERE IT JOINS TO THE FRONT WHEEL YOKE ASSEMBLY BROKE COMPLETELY ON THE RIGHT SIDE AND IS SUBSTANTIALLY CRACKED ON THE LEFT SIDE. THE PROBLEM WAS DISCOVERED BEFORE ANY ACCIDENT OCCURRED, BUT THIS IS DEFINITELY A SAFETY DEFECT, PARTICULARLY IN VIEW OF THE FACT THAT THE PRODUCT¿S INTENDED USERS ARE DISABLED TO SOME DEGREE OR ANOTHER. MY WIFE IS DISABLED AND USES THE PRODUCT DAILY TO ASSIST IN HER MOBILITY. THE PRODUCT HAS A RATED WEIGHT CAPACITY OF 600 POUNDS AND MY WIFE HAS NEVER WEIGHED OVER (B)(6). HER PRESENT WEIGHT IS APPROX (B)(6). IT HAS A LIMITED LIFETIME WARRANTY, BUT THE MFR CLAIMS THAT SITTING ON THE SEAL WHILE THE ROLLATOR IS MOVING IN ANY WAY WHATSOEVER VOIDS THE WARRANTY. THIS IS THE SECOND FAILURE OF THIS PRODUCT. EARLIER THE TIRES FAILED AND THE MFR CLAIMED THE WARRANTY WAS VOIDED FOR THE SAME REASON. (B)(6). MFR DENIED RESPONSIBILITY AND WARRANTY COVERAGE. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
181440 NOVA MIGHTY MACK ROLLATOR WHEELED WALKER ROLLATOR MOBILITY AID ITJ NOVA ORTHO-MED INC. 4216

Patients

Seq Age Sex Outcome Treatment
1 68 YR