BEUDAMED
    FDA Adverse Event Death Summary report: N

    VARIHESIVE XTHIN SURGICAL9X15CM1X10PK DE

    MDR report key: 5113234 · Received September 30, 2015

    Report

    Report Number
    1049092-2015-30114
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    May 1, 2011
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4) AND PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 THAT THE DRESSING ADHERED TO THE BLISTERS AND CAUSED INTENSE PAIN & TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645576 VARIHESIVE XTHIN SURGICAL9X15CM1X10PK DE DRESSING,WOUND,OCCLUSIVE NAD CONVATEC INC. 187920 8H35289

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention COLPOL