BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A5514 REGULAR ACCOMM CUSTOM INSOLES

    MDR report key: 12256606 · Received July 30, 2021

    Report

    Report Number
    3008579854-2021-00001
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    May 10, 2021
    Report Date
    July 30, 2021
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY HAD SEVERE ALLERGIC REACTION TO THE CUSTOM INSOLES. ON THE SECOND DAY, HER FEET STARTED BURNING AND SHE HAD TO GO BACK TO THE DPM. ALL THE SKIN ON HER FEET WAS PEELING AND THE DOCTOR HAD TO REMOVE IT. THE PRODUCT WAS RETURNED TO DJO FOR INVESTIGATION. AFTER EVALUATING THE PRODUCT, NO DEFECT COULD BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY HAD SEVERE ALLERGIC REACTION TO THE CUSTOM INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147939 A5514 REGULAR ACCOMM CUSTOM INSOLES INSOLES, MEDICAL KYS 17-0001-0-00000 11082422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other