BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELFA XTR ISL

    MDR report key: 6933790 · Received October 10, 2017

    Report

    Report Number
    1018120-2017-05099
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 13, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE: 09/13/2018. AN INVESTIGATION WAS PERFORMED FOR THE REPORTED CUSTOMER COMPLAINT: ¿THE CUSTOMER REPORTS THEY ARE HAVING DIFFICULTY REMOVING THE BANDAGES THEY RECEIVED IN THEIR ORDER. AFTER SIX DAYS OF USING THE BANDAGES, A SMALL AMOUNT OF SKIN WAS RIPPED OFF. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.¿ NO LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY REPORT (DHR) WAS UNABLE TO BE PERFORMED. HOWEVER, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. IN-PROCESS PROCEDURES ARE ALSO IN PLACE TO PREVENT NONCONFORMING PRODUCT IN THE MANUFACTURING PROCESS. THIS ENSURES COMPONENTS AND FINISHED PRODUCTS MEET ALL QUALITY INSPECTION STANDARDS. THESE CONTROLS INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, STATISTICAL SAMPLINGS, PERIODIC AUDITS, PROCESS INSPECTIONS, MACHINE MAINTENANCE/OPERATION AND PERSONNEL TRAINING AND CERTIFICATION. NO PRODUCT/SAMPLE WAS PROVIDED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. THEREFORE, A COMPREHENSIVE INVESTIGATION WAS UNABLE TO BE CONDUCTED. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THEY ARE HAVING DIFFICULTY REMOVING THE BANDAGES THEY RECEIVED IN THEIR ORDER. AFTER SIX DAYS OF USING THE BANDAGES, A SMALL AMOUNT OF SKIN WAS RIPPED OFF. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714531 TELFA XTR ISL NAD COVIDIEN 7533

    Patients

    Seq Age Sex Outcome Treatment
    1