BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACAST SAW STOP AND AQUA CAST

    MDR report key: 7772611 · Received August 9, 2018

    Report

    Report Number
    MW5079042
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 8, 2018
    Manufacturer
    AQUACAST LINER LLC
    Product Code
    LGF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR AQUA CAST REMOVAL. AN AQUA CAST WITH 4 WRAP AND GORE-TEX AQUA LINER WITH SAW STOP PROTECTIVE STRIP WERE APPLIED AT INITIAL CAST APPLICATION. DURING CAST REMOVAL, THE SAW STOP LINER DID NOT STOP THE SAW BLADE FROM CONTACTING THE PT'S SKIN. IT REMAINS UNK IF TOO MUCH PRESSURE WAS APPLIED TO THE SAW BLADE DURING CAST REMOVAL, AND QUESTIONS REMAIN IF THE SAW STOP STRIP FUNCTIONED AS INTENDED DURING THIS CASE. THE PT SUSTAINED A 2.5 FULL THICKNESS LACERATION TO THE LEFT LATERAL MALLEOLUS WHICH REQUIRED SURGICAL REPAIR. THE PRODUCT WAS NOT EXPIRED AT THE TIME OF APPLICATION OR REMOVAL, THE TECH DOING REMOVAL WAS UP TO DATE ON TRAINING AND COMPETENCY AT TIME OF THE EVENT WITH EXPERIENCE REMOVING PEDIATRIC CASTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607575 AQUACAST SAW STOP AND AQUA CAST COMPONENT CAST LGF AQUACAST LINER LLC SS30 9D7387_91F010416E

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization