BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90043179 TELFA ADH PD 2X3 100'S STRL

    MDR report key: 5214608 · Received November 10, 2015

    Report

    Report Number
    1282497-2015-00063
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Report Date
    October 20, 2015
    Manufacturer
    STRUKMYER MEDICAL
    Product Code
    NAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 11/10/2015. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/02/2016 THE MDR WAS ENTERED IN ERROR. THE TYPE OF GAUZE IS NOT USED IN A SURGICAL SETTING AND THEREFORE POSES NO RISK TO THE PATIENT FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE DRESSING. THE REPRESENTATIVE REPORTS TELFA PAD BREAKING DOWN AND COMING APART BEFORE DRESSING HAS BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744661 90043179 TELFA ADH PD 2X3 100'S STRL GAUZE DRESSING NAD STRUKMYER MEDICAL 6017 28796

    Patients

    Seq Age Sex Outcome Treatment
    1