BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP PACK

    MDR report key: 7242126 · Received February 5, 2018

    Report

    Report Number
    1423395-2018-00003
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    January 12, 2018
    Report Date
    February 5, 2018
    Manufacturer
    ANDOVER HEALTHCARE INC
    Product Code
    OJH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE A SURGEON CANCELLED A CASE AFTER A PATIENT WAS ALREADY UNDER ANESTHESIA DUE TO UNROLLING COFLEX WRAP AND FINDING AN UNKNOWN BUG IN THE COFLEX WRAP. THIS COFLEX WRAP IS MANUFACTURED BY ANOTHER COMPANY AS STATED. THE COFLEX WRAP WAS UNROLLED PRIOR TO THE START OF A TOTAL HIP REVISION. ACCORDING TO THE FACILITY, THE PATIENT WAS PREPPED FOR SURGERY AND THE OPERATING ROOM STAFF WERE DRAPING THE PATIENT'S LEG AT THE TIME THE BUG WAS DISCOVERED. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM. THE PATIENT REPORTEDLY RECOVERED WITHOUT INCIDENT. THE PATIENT INVOLVED IN THE INCIDENT WAS REQUIRED TO RETURN TO HAVE THE TOTAL HIP REVISION COMPLETED. NO INJURY WAS REPORTED, HOWEVER THE PATIENT WAS REQUIRED TO UNDERGO ANESTHESIA FOR A SECOND TIME TO COMPLETE THIS PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. A SAMPLE IS AVAILABLE AND WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORTED ISSUE OF A BUG IN THE COFLEX WRAP WAS CONFIRMED AND THE INITIAL MANUFACTURER WAS NOTIFIED OF THE EVENT. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUG WAS FOUND WHILE UNROLLING A COFLEX WRAP BEFORE THE START OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85657 HIP PACK OJH ANDOVER HEALTHCARE INC 17YM1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other