BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIVA XC ADH 10X10CM 1X16PK STER FR

    MDR report key: 5113209 · Received September 30, 2015

    Report

    Report Number
    1000317571-2015-30115
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    June 20, 2012
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    IT WAS REPORTED A FOREIGN OBJECT (PAPER) IS ATTACHED TO THE FRONT OF THE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645700 VERSIVA XC ADH 10X10CM 1X16PK STER FR DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LIMITED 410629 1E00340

    Patients

    Seq Age Sex Outcome Treatment
    1