BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUTCH TIP

    MDR report key: 3143142 · Received May 30, 2013

    Report

    Report Number
    1417592-2013-00048
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    February 6, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    INP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT THE CRUTCH TIPS WORE THROUGH, CAUSING HIM TO FALL. HE WAS ORIGINALLY EVALUATED AND REPORTED TO US THAT NO SERIOUS INJURY RESULTED. ON (B)(6) 2013, HE NOTIFIED US THAT HE WAS LATER DIAGNOSED WITH A TORN ROTATOR CUFF. WE DO NOT KNOW IF THE CRUTCH TIPS WERE USED ON MEDLINE CRUTCHES OR IF HIS WEIGHT WAS WITHIN THE CRUTCHES' WEIGHT LIMITATIONS. THE CRUTCH TIPS WERE RETURNED FOR EVALUATION. THEY WERE WORN ON THE EDGES BUT NOT COMPLETELY WORN THROUGH. THE INTEGRITY OF THE CENTER OF THE TIP WAS NOT COMPROMISED. THE WORN EDGES SUGGEST THAT WHILE AMBULATING WITH THE CRUTCHES, THE END USER MAY HAVE EXERTED HIS WEIGHT ON THE EDGES OF THE TIPS RATHER THAN THE CENTER, AS IS INTENDED.

    Description of Event or Problem · 1

    THE END USER FELL WHILE AMBULATING WITH CRUTCHES. HE WAS LATER DIAGNOSED WITH A TORN ROTATOR CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240124 CRUTCH TIP INP MEDLINE INDUSTRIES, INC. R120654447

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other