BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 554286 · Received November 9, 2004

    Report

    Report Number
    1034548-2004-00016
    Event Type
    Other
    Date Received
    November 9, 2004
    Report Date
    November 9, 2004
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORT STATES THE PRODUCT WAS USED FOR A LACERATION CLOSURE. THE END USER SUSPECTED PRODUCT STERILITY WAS COMPROMISED. NO INFO HAS BEEN PROVIDED TO SUPPORT THIS CLAIM. ETHICON INC. HAS SENT THE USER QUESTIONS CONCERNING THE EVENT, BUT AT THIS TIME NO MORE INFO HAS BEEN PROVIDED. PRODUCT WAS RETURNED. THE CURRENT CONDITION OF THE PT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND TOPICAL SKIN ADHESIVE TISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION MPN CLOSURE MEDICAL CORP. NA 014005

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other