BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL

    MDR report key: 1712555 · Received June 3, 2010

    Report

    Report Number
    2243969-2010-00022
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 6, 2010
    Manufacturer
    CONVATEC
    Product Code
    KMF
    PMA / PMN Number
    K943258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    REPORTED FROM CLINICAL TRIAL IN (B) (4) FOR PRODUCT MARKETED IN THE USA: EVENT: NECROSIS EVOLUTION OF THE ULCER (AGGRAVATION OF STUDY LEG ULCER) AND SURINFECTION OF STUDY ULCER S. AUREUS AND P AERUGINOSE. TREATMENT: BIANTIBIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUACEL ABSORBENT ANTIMICROBIAL WOUND DRESSING KMF CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention