BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 3232576 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-07518
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A PARTIAL LAPAROSCOPIC ASSISTED SUB-TOTAL HYSTERECTOMY ON (B)(6) 2011 AND TOPICAL SKIN ADHESIVE WAS USED. APPROXIMATELY SEVEN DAYS POST OPERATIVE, THE PATIENT DEVELOPED ITCHING AND REDNESS AT THE SURGICAL SITE. SHE THEN DEVELOPED A RED RASH AT THE SITE. THE PATIENT WAS PRESCRIBED BENADRYL 25-50MG EVERY 4-6 HOURS, TOPICAL HYDROCORTISONE CREAM, AND INSTRUCTED TO REMOVE THE TOPICAL ADHESIVE. THE REACTION SUBSIDED IN FIVE TO SIX WEEKS. THE PATIENT STATES THE SITE WAS TENDER FOR FIVE MONTHS BUT SHE NOW FEELS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336231 DERMABOND 2 ADHESIVE, TOPICAL SKIN MPN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention