BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 461073 · Received May 16, 2003

    Report

    Report Number
    1034548-2003-00011
    Event Type
    Other
    Date Received
    May 16, 2003
    Date of Event
    March 28, 2003
    Report Date
    May 16, 2003
    Manufacturer
    CLOSURE MEDICAL CORPORATION
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    1) ER PHYSICIAN USED PRODUCT TO REPAIR LACERATION ON A PATIENT IN THE ER ON 2003. 2) WHEN VIAL WAS CRUSHED A PIECE OF GLASS AMPOULE CAME THROUGH THE BUTYRATE TUBE AND CUT THE INDEX FINGER. 3) DOCTOR THOUGHT IT WAS A SUPERFICIAL CUT, DOCTOR DID NOT REALIZE DR HAD GLASS EMBEDDED IN THEIR FINGER. 4) FIVE DAYS LATER THE DOCTOR DEVELOPED AN ABSCESS ON FINGER. 5) IN 4/03 AN X-RAY REVEALED THE GLASS SHARD IN THE FINGER. 6) A SURGEON REMOVED TWO PIECES OF GLASS APPROXIMATELY 3/4 CM. IN SIZE FROM THE SITE. 7) NO ANESTHESIA WAS USED. 8) NO ANTIBIOTICS WERE PRESCRIBED. 9) TWO STITCHES WERE PLACED IN FINGER. 10) TOPICAL MEDICATION USED ON THE WOUND. 11) WOUND HEALED IN 2-3 WEEKS AND TENDERNESS IS GONE FROM THE FINGER. 12) THE AMPOULE WAS THROWN AWAY IN THE SHARPS CONTAINER SO IT IS NOT AVAILABLE FOR EVALUATION.

    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 CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other