BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADAPTIC NON-ADHERING DRESSING

    MDR report key: 2195317 · Received June 29, 2011

    Report

    Report Number
    3007663067-2011-00003
    Event Type
    Other
    Date Received
    June 29, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN. NO PRODUCT CODE OR LOT NUMBER WAS PROVIDED. SYMPTOMS WERE TREATED WITH DERMOCORTICOIDE. PT CONDITION NOW IS DESCRIBED AS FINE. LIST OF DRESSING COMPONENTS SENT TO THE DOCTOR FOR IDENTIFICATION OF POTENTIAL ALLERGEN.

    Description of Event or Problem · 1

    A KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING WAS USED ON POST-OP WOUND IN (B)(6). PT SUFFERED AN ALLERGIC REACTION WITH "BLEB" (LARGE BLISTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTIC NON-ADHERING DRESSING SURGICAL WOUND, NON-ADHERING DRESSING FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other