BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE PROPEN DOMESTIC

    MDR report key: 546946 · Received September 28, 2004

    Report

    Report Number
    1034548-2004-00014
    Event Type
    Other
    Date Received
    September 28, 2004
    Report Date
    September 28, 2004
    Manufacturer
    CLOSURE MEDICAL CORP.
    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 COMPLAINT FILE WAS OPENED AT ETHICON, INC. IN 9/2004, THE EVENT OCCURRED WITHIN THE TWO WEEKS PRIOR TO THAT DATE. THE REPORT STATES THE PRODUCT WAS USED TO CLOSE A FACIAL LACERATION ON A PT OF UNKNOWN GENDER OR AGE. THE WOUND WAS THOROUGHLY CLEANED BY THE ATTENDING DOCTOR, HOWEVER THERE IS SOME INDICATION THAT THE WOUND WAS NOT WELL APPROXIMATED. THERE HAVE BEEN SEVERAL ATTEMPTS TO GAIN MORE INFORMATION ON THIS EVENT, BUT AT THIS TIME NO MORE INFORMATION HAS BEEN PROVIDED. PRODUCT WAS NOT RETURNED. THE CURRENT CONDITION OF THE PT IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other