BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 389174 · Received March 18, 2002

    Report

    Report Number
    1034548-2002-00020
    Event Type
    Other
    Date Received
    March 18, 2002
    Date of Event
    November 13, 2001
    Manufacturer
    CLOSURE MEDICAL CORP
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    FROM EVENT DESCRIPTION SUBMITTED BY DISTRIBUTOR: OTHERWISE UNSPECIFIED BRAIN STEM SURGERY WAS PERFORMED IN 2001 AND DERMABOND TOPICAL SKIN ADHESIVE WAS USED FOR TOPICAL WOUND CLOSURE. NO SPECIFICS ARE PROVIDED, BUT THE CONTENT IS SUGGESTIVE THAT SOME TYPE OF POST-OPERATIVE INFECTION OCCURRED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention