BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMABOND

    MDR report key: 1131843 · Received August 19, 2008

    Report

    Report Number
    1131843
    Event Type
    Death
    Date Received
    August 19, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 18, 2008
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT (MEDICAL HISTORY NOTED BELOW) PRESENTED TO THE EMERGENCY DEPARTMENT WITH A 24 HOUR HISTORY OF MELANOTIC STOOLS. PT UNDERWENT URGENT ESOPHAGOGASTRODUODENOSCOPY WITH GLUE INJECTION (DERMABOND) AND ARGON PLASMA COAGULATION. A GIANT ESOPHAGEAL VARIX WAS IDENTIFIED IN THE STOMACH. INITIAL ATTEMPTS WERE MADE TO TREAT THE LESION WITH AN ENDOLOOP BUT THE LOOP SLIPPED OFF OF THE VARIX DURING CLOSURE AND WAS REMOVED. A SCLEROTHERAPY NEEDLE WAS USED TO PUNCTURE THE VARIX TO INJECT GLUE. THE PUNCTURES WERE UNEVENTFUL. TWO OTHER PUNCTURES WERE MADE FOR A TOTAL OF APPROX 7 CC OF DERMABOND INJECTION. THERE WAS MINIMAL BLEEDING NOTED. THE VARIX APPEARED TO HAVE BECOME FIRM. AS THE ENDOSCOPE WAS REMOVED, THE PT'S OXYGEN SATURATION, WHICH HAD BEEN IN THE 90S, BEGAN TO FALL INTO THE 80'S. REVERSAL AGENTS WERE ADMINISTERED TO REVERSE THE NARCOTICS. DESPITE THIS, THE PT'S BREATHING BECAME LABORED AND HIS OXYGEN SATURATION DROPPED INTO THE 50'S. A CODE WAS CALLED, PT INTUBATED. THE PT'S PULSE AND BLOOD PRESSURE WERE LOST AND CPR WAS INSTITUTED. DESPITE MAXIMUM RESUSCITATIVE EFFORTS, THE PT COULD NOT BE RESUSCITATED.

    Description of Event or Problem · 1

    PT (MEDICAL HISTORY NOTED BELOW) PRESENTED TO THE EMERGENCY DEPARTMENT WITH A 24 HOUR HISTORY OF MELANOTIC STOOLS. PT UNDERWENT URGENT EOSPHAGOGASTRODUODENOSCOPY WITH GLUE INJECTION (DERMABOND) AND ARGON PLASMA COAGULATION. A GIANT ESOPHAGEAL VARIX WAS IDENTIFIED IN THE STOMACH. INITIAL ATTEMPTS WERE MADE TO TREAT THE LESION WITH AN ENDOLOOP BUT THE LOOP SLIPPED OFF OF THE VARIX DURING CLOSURE AND WAS REMOVED. A SCLEROTHERAPY NEEDLE WAS USED TO PUNCTURE THE VARIX TO INJECT GLUE. THE PUNCTURES WERE UNEVENTFUL. TWO OTHER PUNCTURES WERE MADE FOR A TOTAL OF APPROX 7 CC OF DERMABOND INJECTION. THERE WAS MINIMAL BLEEDING NOTED. THE VARIX APPEARED TO HAVE BECOME FIRM. AS THE ENDOSCOPE WAS REMOVED, THE PT'S OXYGEN SATURATION, WHICH HAD BEEN IN THE 90S, BEGAN TO FALL INTO THE 80'S. REVERSAL AGENTS WERE ADMINISTERED TO REVERSE THE NARCOTICS. DESPITE THIS, THE PT'S BREATHING BECAME LABORED AND HIS OXYGEN SATURATION DROPPED INTO THE 50'S. A CODE WAS CALLED, PT INTUBATED. THE PT'S PULSE AND BLOOD PRESSURE WERE LOST AND CPR WAS INSTITUTED. DESPITE MAXIMUM RESUSCITATIVE EFFORTS, THE PT COULD NOT BE RESUSCITATED.

    Description of Event or Problem · 1

    PT (MEDICAL HISTORY NOTED BELOW) PRESENTED TO THE EMERGENCY DEPT WITH A 24 HOUR HISTORY OF MELANOTIC STOOLS. PT UNDERWENT URGENT ESOPHAGOGASTRODUODENOSCOPY WITH GLUE INJECTION (DERMABOND) AND ARGON PLASMA COAGULATION. A GIANT ESOPHAGEAL VARIX WAS IDENTIFIED IN THE STOMACH. INITIAL ATTEMPTS WERE MADE TO TREAT THE LESION WITH AN ENDOLOOP BUT THE LOOP SLIPPED OFF OF THE VARIX DURING CLOSURE AND WAS REMOVED. A SCLEROTHERAPY NEEDLE WAS USED TO PUNCTURE THE VARIX TO INJECT GLUE. THE PUNCTURES WERE UNEVENTFUL. TWO OTHER PUNCTURES WERE MADE FOR A TOTAL OF APPROX 7 CC OF DERMABOND INJECTION. THERE WAS MINIMAL BLEEDING NOTED. THE VARIX APPEARED TO HAVE BECOME FIRM. AS THE ENDOSCOPE WAS REMOVED, THE PT'S OXYGEN SATURATION, WHICH HAD BEEN IN THE 90'S, BEGAN TO FALL INTO THE 80'S. REVERSAL AGENTS WERE ADMINISTERED TO REVERSE THE NARCOTICS. DESPITE THIS, THE PT'S BREATHING BECAME LABORED AND HIS OXYGEN SATURATION DROPPED INTO THE 50'S. A CODE WAS CALLED, PT INTUBATED. THE PT'S PULSE AND BLOOD PRESSURE WERE LOST AND CPR WAS INSTITUTED. DESPITE MAXIMUM RESUSCITATIVE EFFORTS, THE PT COULD NOT BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND TOPICAL SKIN ADHESIVE MPN CLOSURE MEDICAL CORP. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death