BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE

    MDR report key: 4132817 · Received September 29, 2014

    Report

    Report Number
    1000317571-2014-11341
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K080383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED 04/16/2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. BATCH RECORD WAS REVIEWED, ALL CHECKS WERE CARRIED OUT AND THE DIMENSIONS WERE MANUFACTURED TO SPECIFICATION. THE SAMPLE IN THE BATCH RECORD WAS MEASURED AND FOUND TO MEET SPECIFICATION.

    Description of Event or Problem · 1

    PER THE END USER, THE WRONG SIZE DRESSING WAS IN THE BOX. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606079 AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE FRO CONVATEC LIMITED 403771 2H00359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other