BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUTCH, ALUMINUM, ADULT TALL 300LB

    MDR report key: 1941781 · Received December 21, 2010

    Report

    Report Number
    1417592-2010-00078
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    May 15, 2009
    Report Date
    December 21, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN (B)(6) 2009, THE END USER WAS PAINTING BASE BOARDS AS A MAINTENANCE WORKER AND INJURED HIS KNEE. WHILE USING CRUTCHES THAT HE WAS GIVEN FOR HIS KNEE INJURY, HE FELL WHEN THE CRUTCH TIPS WORE THROUGH. HE TRIED TO CATCH HIMSELF AND SLAMMED HIS GOOD KNEE ONTO THE FLOOR AND HURT HIS BACK. HE DID NOT REPORT HIS INCIDENT TO US AT THAT TIME. HE RECENTLY HAD AN MRI WHICH IDENTIFIED A HERNIATED LUMBAR DISC. HE STATES THIS BACK CONDITION IS THE RESULT OF THE PREVIOUS FALL. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THE ISSUE HAS NOT BEEN CONFIRMED AND MEDICAL DOCUMENTATION WAS NOT PROVIDED TO INDICATE THE RECENT DIAGNOSIS WAS THE RESULT OF THE EARLIER FALL. HOWEVER, IN AN ABUNDANCE OF CAUTION AND DUE TO THE REPORTED INJURY THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT WHILE USING THE CRUTCHES IN (B)(6) 2009, HE FELL WHEN THE CRUTCH TIPS WORE THROUGH AND INJURED HIS BACK. HE DID NOT REPORT HIS INCIDENT TO US UNTIL NOW. HE WAS RECENTLY DIAGNOSED WITH A HERNIATED DISC WHICH HE STATES WAS A RESULT OF THE EARLIER FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUTCH, ALUMINUM, ADULT TALL 300LB NONE IPR MEDLINE INDUSTRIES, INC. MDS80534 A080936794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention