BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUTCH TIP

    MDR report key: 3021557 · Received March 15, 2013

    Report

    Report Number
    1417592-2013-00023
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT WHILE WALKING IN HIS HOME, THE CRUTCH TIPS WORE THROUGH AND HE FELL. HE STATES HE RE-INJURED HIS SHOULDER THAT HAD PREVIOUSLY BEEN SURGICALLY REPAIRED AND NOW NEEDS ADDITIONAL SURGICAL INTERVENTION. IT WAS NOT CLEAR WHAT INJURY RESULTED AS HIS REPORT WAS NOT CONSISTENT AND NO MEDICAL DOCUMENTATION WAS PROVIDED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS WERE SENT. THE END USER STATED THAT THE CRUTCHES WERE NOT MANUFACTURED BY MEDLINE, ONLY THE TIPS. THE OVERALL CARE AND CONDITION OF THE CRUTCHES/TIPS IS NOT KNOWN. IT IS NOT KNOWN WHAT ROLE IF ANY, THE CRUTCHES MAY HAVE PLAYED IN THE REPORTED INCIDENT. AT THIS TIME WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A ROOT CAUSE. HOWEVER, DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE CRUTCH TIPS WORE THROUGH AND THE END USER FELL. HE STATES HE RE-INJURED HIS SHOULDER WHICH REQUIRES SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110067 CRUTCH TIP IPR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R