BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL® TRU-SHAPE¿

    MDR report key: 8773364 · Received July 9, 2019

    Report

    Report Number
    2135139-2019-00001
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 2, 2019
    Manufacturer
    THE COMFORT COMPANIES, L.L.C.
    Product Code
    IMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE SEVERITY OF THE ALLEGED INJURY AND TREATMENT REQUIRED. AT THIS TIME, NO RESPONSES HAVE BEEN RECEIVED FROM THE END USER. EVALUATION OF THE DEVICE HISTORY INDICATES THAT THE REMAKE WAS BUILT TO ORDER SPECIFICATIONS, BUT SIZE REQUESTED BY END USER WAS TWO INCHES TOO LARGE IN WIDTH. AN INJURY ALLEGATION WAS SUBMITTED; HOWEVER, MEDICAL RECORDS ARE NOT ACCESSIBLE TO CONFIRM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER ATP (ASSISTIVE TECHNOLOGY PROFESSIONAL)- WE ORDERED TWO MOLDS ALL OFF THE SAME FILE, AND THEY KEEP COMING IN DIFFERENT. THE ONE FOR HIS PWC KEEPS COMING IN WIDER THAN THE OTHER, AND NOW HE HAS DEVELOPED SKIN BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565641 PERMOBIL® TRU-SHAPE¿ TRU-SHAPE IMP THE COMFORT COMPANIES, L.L.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other