BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACELL AG SURGICAL (SCD)

    MDR report key: 4820640 · Received June 4, 2015

    Report

    Report Number
    1049092-2015-00304
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 26, 2015
    Manufacturer
    CONVATEC, INC
    Product Code
    FRO
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE END USER REPORTED THAT HE DEVELOPED BLISTERING UNDER TAPE BORDER ON HIS RIGHT HIP, TWELVE HOURS AFTER A SURGICAL PROCEDURE. HE CONTINUED TO WEAR THE DRESSING FOR THREE DAYS. ON AN UNK DATE, DURING A FOLLOW UIP VISIT, THE PHYSICIAN REMOVED DRESSING AND NOTED BLISTERED AREA TO BE 76MM BY 76MM. ON (B)(6) 2015, THE PT IS SCHEDULED FOR A SKIN GRAFT OVER AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362393 AQUACELL AG SURGICAL (SCD) DRESSING, WOUND, DRUG FRO CONVATEC, INC 412009

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention