BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 530902 · Received March 2, 2004

    Report

    Report Number
    1034548-2004-00003
    Event Type
    Other
    Date Received
    March 2, 2004
    Report Date
    March 1, 2004
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS USED TO CLOSE SKIN AFTER A VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO OOPHERECTOMY. THE EVENT WAS CLASSIFIED AS AN INFECTION. THE PT WAS GIVEN CIPRO FOR SEVEN DAYS. THE DISTRIBUTOR MADE AT LEAST FOUR ATTEMPTS TO GAIN MORE INFO ABOUT THE EVENT WITHOUT SUCCESS. AT THIS TIME NO ADDITIONAL INFO HAS BEEN PROVIDED. FACILITY HAS STATED THAT NO FURTHER INFO WILL BE PROVIDED. PRODUCT WAS NOT RETURNED.

    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 Other