BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-TRAK (LARGE) ANCHORING DEVICE 50PACK

    MDR report key: 6123254 · Received November 22, 2016

    Report

    Report Number
    1000317571-2016-00092
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    CONVATEC LIMITED
    Product Code
    KGZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT TYPE OF REPORTABLE EVENT TO MALFUNCTION WHICH WAS SUBMITTED INCORRECTLY IN ERROR FOR THE INITIAL MDR (MFR REPORT# 1000317571-2016-00092) ON NOVEMBER 22, 2016. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION AND A NON-SERIOUS PATIENT INJURY. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM A NURSE REPORTING THAT ON TWO (2) SEPARATE INCIDENCES WHEN THE ANCHORING DEVICE DID NOT ADHERE WELL TO THE SKIN AND CAUSED THE CATHETER TO MOVE AND TEAR THE URETHRAL MUCOSAL TISSUE." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773001 FLEXI-TRAK (LARGE) ANCHORING DEVICE 50PACK ACCESSORIES, CATHETER KGZ CONVATEC LIMITED 37449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other