BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2862339 · Received December 10, 2012

    Report

    Report Number
    9616091-2012-00612
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9SL , SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1056953 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. IN SPEAKING WITH THE REPORTER, IT WAS LEARNED OF THE FOLLOWING: HE SAID THERE WAS NO DAMAGE TO HER LEG JUST PAIN AND DID NOT AFFECT THE RECENT SURGERY AND PROBLEM SHE WAS HAVING WITH HER KNEE. CONSUMER STATES THE CHAIR WAS A RENTAL AND THEY ALREADY RETURNED THE CHAIR AND THE LEGRESTS. IT WAS ALSO REPORTED THAT THE END USER SOUGHT A VERBAL CONSULT WITH HER SURGEON TO SEE IF SHE HAS DAMAGED HER KNEE. THE SYMPTOMS WERE SWELLING AND PAIN IN HER KNEE. HER HUSBAND IS APPLYING ICE PACKS. THIS INCIDENT WILL BE FILED AS A SERIOUS INJURY SINCE THE END USER SOUGHT MEDICAL EVALUATION DUE TO THE INCIDENT. IT APPEARS NO FURTHER TREATMENT OR INTERVENTION WAS PROVIDED. THE USER HAS NOT REPORTED WHAT TYPE OR REASON FOR THE RECENT SURGICAL PROCEDURE SHE HAD UNDERGONE PRIOR TO THIS INCIDENT.

    Description of Event or Problem · 1

    THE PLASTIC PART OF THE LEG CALF HAS BROKE AND WHEN THIS HAPPENED HIS WIFE'S HEAL HIT THE FLOOR. REPORTEDLY THE INCIDENT RESULTED IN PAIN IN HER KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 Other| R