BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURO ELASTIC BANDAGE WITH CLIPS

    MDR report key: 2029736 · Received March 21, 2011

    Report

    Report Number
    2110898-2011-00028
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    July 30, 2010
    Report Date
    March 8, 2011
    Manufacturer
    BIERSDORF INC.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: PRODUCT NOT RETURNED. RESULTS: CLIP IS USED TO SECURE ELASTIC BANDAGE. CLIP HOOK IS NOT INTENDED TO COME IN DIRECT CONTACT WITH SKIN. CONCLUSION: CLIP IS USED TO SECURE ELASTIC BANDAGE. CLIP HOOK IS NOT INTENDED TO COME IN DIRECT CONTACT WITH SKIN. 3M COMPANY ACQUIRED THE FUTURO TRADE NAME AND PRODUCT LINE IN Q4 OF 2008. PRODUCT ARTWORK WAS NOT UPDATED TO LIST 3M AS THE MFR AS THE PRODUCT WAS DISCONTINUED.

    Description of Event or Problem · 1

    A CONSUMER DEVELOPED BACK PROBLEMS AND SWOLLEN ANKLES. AN ELASTIC BANDAGE WAS WRAPPED ON HIS LOWER LEFT LEG. IN THE PROCESS OF WRAPPING THE LEG, IT WAS PUNCTURED IN TWO PLACES FROM THE CLIPS USED TO SECURE THE BANDAGE. AN INFECTION DEVELOPED AT THE SITE OF THE INFECTION. THE CONSUMER WAS HOSPITALIZED TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURO ELASTIC BANDAGE WITH CLIPS 880.5075 ELASTIC BANDAGE, FDA CODE FQM FQM BIERSDORF INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization