BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2233919 · Received September 6, 2011

    Report

    Report Number
    1525712-2011-00492
    Date Received
    September 6, 2011
    Date of Event
    April 17, 2011
    Report Date
    September 2, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. INVACARE PROVIDES USER INSTRUCTIONS WITH ALL ROLLATORS. THE USER INSTRUCTIONS PROVIDE WARNINGS, CAUTIONS AND INSTRUCTIONS FOR THE SAFETY OF THE CONSUMER AND CORRECT OPERATION OF THE DEVICE. THE MODEL AND SERIAL NUMBER ARE UNKNOWN. FOR DOCUMENTATION MODELS 65400 AND 65420 WITH A USER MANUAL OF PN 1076166 WILL BE USED AS AN ILLUSTRATION OF WHAT THE CONSUMER IS PROVIDED. IT IS UNKNOWN IF THE DEALER AND CONSUMER FULLY READ AND UNDERSTAND THE USER INSTRUCTIONS PROVIDED. ON PAGE 1 - "GENERAL WARNINGS: DO NOT INSTALL THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS INSTRUCTION SHEET. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS AND INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL IF APPLICABLE BEFORE ATTEMPTING TO INSTALL THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR." IT IS UNKNOWN IF THE CONSUMER WAS PRESCRIBED THE DEVICE BY A QUALIFIED MEDICAL PROVIDER. "A PHYSICAL/OCCUPATIONAL THERAPIST SHOULD ASSIST IN THE PLACEMENT AND POSITIONING OF THE HAND GRIPS FOR MAXIMUM SUPPORT AND CORRECT BRAKE ACTIVATION." IT IS UNKNOWN IF THE DEVICE WAS BALANCED PROPERLY. "BE SURE THE ROLLATOR IS PROPERLY BALANCED BEFORE USING." IT IS UNKNOWN IF THE PROPER HEIGHT ADJUSTMENTS WERE MADE. "CARE SHOULD BE TAKEN TO ENSURE THAT ALL HAND AND HEIGHT ADJUSTMENTS ARE SECURE, AND THAT CASTERS AND MOVING OBJECTS ARE IN GOOD WORKING ORDER BEFORE USING THIS OR ANY MOBILITY AID." IT IS UNKNOWN IF THE WHEELS WERE IN CONTACT WITH THE FLOOR AT THE TIME OF THE INCIDENT. "ALL WHEELS MUST BE IN CONTACT WITH THE FLOOR AT ALL TIMES DURING USE." IT IS UNKNOWN IF THE BRAKES WERE LOCKED BEFORE USE. "ON MODEL 65420, THE BRAKES MUST BE IN THE LOCKED POSITION BEFORE USING THE SEAT." IT IS NOT KNOWN IF THE CONSUMER WAS TRYING TO PROPEL THEMSELVES ON THE ROLLATOR. "THE ROLLATOR IS NOT INTENDED FOR PROPELLING WHILE SEATED. IT IS NOT TO BE PUSHED AND/OR USED AS A WHEELCHAIR." THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN IS UNKNOWN. "THE ROLLATOR IS DESIGNED TO PROVIDE SUPPORT, INCREASED STABILITY AND ASSISTANCE TO THE END USER WHILE WALKING. " THE WEIGHT OF THE CONSUMER IS UNKNOWN. "THE 3-WHEEL ROLLATOR IS NOT DESIGNED TO SUPPORT THE TOTAL WEIGHT OF AN INDIVIDUAL AND HAS A WEIGHT LIMITATION OF 250 LBS. (114KG.). THE 4-WHEEL ROLLATOR CAN PROVIDE AMBULATORY ASSISTANCE FOR AN INDIVIDUAL WEIGHING UP TO 270 LBS. (123KG.), INCLUDING THE WEIGHT OF THE CONTENTS OF THE BASKET AND TRAY. THE SEAT ON MODEL 65420 CAN SUPPORT AN INDIVIDUAL WEIGHING UP TO 270 LBS. (123 KG.). THE ROLLATOR BASKET HAS A WEIGHT LIMIT OF 15 LBS. (6 KG.). THE ROLLATOR TRAY HAS A WEIGHT LIMIT OF 5 LBS. (4.5 KG.). " IT IS UNKNOWN IF THE DEVICE WAS SET UP PROPERLY. "INSTALLATION WARNINGS: ALWAYS TEST TO SEE THAT THE ROLLATOR IS PROPERLY AND SECURELY LOCKED WHEN IN THE OPEN POSITION BEFORE USING. THE ROLLATOR HEIGHT CAN ONLY BE ADJUSTED WHERE THE PUSH HANDLE IS TEXTURED (FIGURE 3). AFTER INSTALLATION AND BEFORE USE, ENSURE THAT ALL ATTACHING HARDWARE IS SECURELY TIGHTENED."

    Description of Event or Problem · 1

    IVC LEGAL RECEIVED INFORMATION ALLEGING THE CONSUMER WAS INJURED WHEN THE LEFT REAR WHEEL AND COMPONENT PARTS ALLEGEDLY UNEXPECTEDLY FAILED BY DETACHING. ALTHOUGH SERIOUS INJURY IS ALLEGED, DETAILS ARE NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other