BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A5513 ACCOMM WHITE BASE+ BLUE TOP SUB-ASSY

    MDR report key: 16414699 · Received February 21, 2023

    Report

    Report Number
    9616086-2023-00004
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 24, 2023
    Report Date
    February 21, 2023
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED BLISTERS ON BOTH ARCHES THAT ARE NOW WOUNDS AFTER 3 DAYS OF WEARING THE INSERTS. THE PATIENT REQUIRED WOUND CARE TO TREAT THE WOUNDS. THE INSERTS HAVE NOT BEEN RETURNED TO ENOVIS FOR EVALUATION. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF THE INSERTS ARE RETURNED OR MORE INFORMATION COMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED BLISTERS ON BOTH ARCHES THAT ARE NOW WOUNDS AFTER 3 DAYS OF WEARING THE INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227933 A5513 ACCOMM WHITE BASE+ BLUE TOP SUB-ASSY INSOLES, MEDICAL KYS DJO LLC 12-3106-0-02000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other