BEUDAMED
    FDA Adverse Event Summary report: N

    DME COMPANY BECKER ORTHOPEDICS

    MDR report key: 4239349 · Received August 18, 2014

    Report

    Report Number
    4239349
    Date Received
    August 18, 2014
    Date of Event
    July 19, 2014
    Report Date
    August 18, 2014
    Manufacturer
    *
    Product Code
    ILG
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT CAME TO THE ED WITH GANGRENE AND UNDERWENT AN EMERGENT BKA (BELOW KNEE AMPUTATION). PATIENT WAS QUITE ILL AND HAD NUMEROUS COMORBIDITIES.THE PATIENT HAD A BKA AND A STUMP SHRINKER IN PLACE THAT MAY HAVE CONTRIBUTED TO NECROSIS AND HARM. THIS RESULTED IN ADVANCEMENT TO AN AKA (ABOVE KNEE AMPUTATION). MD SUGGESTION TO PREVENT ANY POTENTIAL PROBLEMS: MANUFACTURER SHOULD UPDATE THEIR PROCESSES TO INCLUDE CONSULTING WITH A PATIENT'S RN WHEN THEY PLACE AN ORTHOTIC SHRINKER ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496686 DME COMPANY BECKER ORTHOPEDICS STOCKING, ELASTIC ILG * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR