BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABON TOPICAL SKIN ADHESIVE

    MDR report key: 597532 · Received April 28, 2005

    Report

    Report Number
    1034548-2005-00008
    Event Type
    Other
    Date Received
    April 28, 2005
    Report Date
    April 28, 2005
    Manufacturer
    CLOSURE MEDICAL CORPORATION
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS REPORTED BY A SURGEON TO HAVE BEEN INVOLVED IN TWO INFECTIONS. PRODUCT CODES UNKNOWN, LOTS UNKNOWN, EVENT DATES UNKNOWN. THERE HAS BEEN NO RESPONSE TO THE LETTER OUR DISTRIBUTOR, ETHICON, INC. SENT TO SURGEON REQUESTING INFORMATION. THERE ARE NO KNOWN DETAILS ABOUT THESE EVENTS. PRODUCTS WAS NOT RETURNED. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THIS REPORT WILL APPLY TO THE SECOND OF THE TWO EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABON TOPICAL SKIN ADHESIVE TISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION MPN CLOSURE MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other