BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCARE

    MDR report key: 20627238 · Received November 7, 2024

    Report

    Report Number
    9616086-2024-00099
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 14, 2024
    Report Date
    November 6, 2024
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    E317265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT METAL BARS BROKE THROUGH THE STITCHING AND INTO PATIENTS SKIN, CAUSING THE SKIN TO BREAK AND BLEED OUT AND ONTO THE ORIGINAL PRODUCT, NEW PRODUCT WAS PROVIDED BECAUSE OF THE INITIAL INJURY. CLINIC DISCARDED THIS PRODUCT PRIOR TO THE REP VISIT WITH THE PATIENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT METAL BARS BROKE THROUGH THE STITCHING AND INTO PATIENTS SKIN, CAUSING THE SKIN TO BREAK AND BLEED OUT AND ONTO THE ORIGINAL PRODUCT, NEW PRODUCT WAS PROVIDED BECAUSE OF THE INITIAL INJURY. CLINIC DISCARDED THIS PRODUCT PRIOR TO THE REP VISIT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861009 PROCARE 20" UNIV BASIC KNEE SPLINT KYS DJO LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other