BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 376967 · Received February 13, 2002

    Report

    Report Number
    1034548-2002-00011
    Event Type
    Other
    Date Received
    February 13, 2002
    Date of Event
    January 22, 2002
    Report Date
    February 13, 2002
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR REPORT, DERMABOND(R) ADHESIVE WAS USED TO CLOSE A LACERATION BETWEEN THE EYEBROW AND EYE. THE FAMILY MEMBER REPORTS THAT THE PT WAS LYING FLAT ON THEIR BACK. PT DID NOT MOVE AROUND; FAMILY MEMBERS WERE RESTRAINING PT IN CASE PT DID. NO PRECAUSTIONS WERE TAKEN TO PROTECT THE EYE. PETROLEUM JELLY OR GAUZE WAS NOT PLACED AROUND THE EYE. DURING THE PROCEDURE, THE ADHESIVE RAN AND GLUED THE RIGHT EYE SHUT. THE PT WAS GIVEN DEMEROL TO CALM DOWN PT IN ORDER TO OPEN THE EYE. THE PHYSICIAN WAS UNSUCCESSFUL. PT VISITED AN OPTHAMOLOGIST 2 DAYS AFTER THE EVENT. NO TREATMENT WAS PERFORMED. THE OPTHAMOLOGIST ANTICIPATED THAT THE ADHESIVE WOULD PEEL OFF IN 7 TO 10 DAYS.

    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 4 YR Other