BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND

    MDR report key: 4250221 · Received November 14, 2014

    Report

    Report Number
    2210968-2014-15769
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 28, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS PERFORMED IN (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 IN A LITERATURE ARTICLE THAT THE PATIENT UNDERWENT BREAST SURGERY TO REPLACE TISSUE EXPANDERS WITH PERMANENT SILICONE IMPLANTS ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. APPROXIMATELY FIVE DAYS POST-OPERATIVELY, THE PATIENT EXPERIENCED ERYTHEMA OF THE RIGHT BREAST THAT BEGAN AROUND THE INCISION LINES AND BEGAN TO EXPAND OUTWARD AND ON POST-OPERATIVE DAY 7 THE PATIENT WENT TO THE EMERGENCY ROOM. THE PATIENT ALSO EXPERIENCED AN ITCHY, RED, MACULOPAPULAR RASH THAT SPREAD ALONG THE ABDOMEN, BACK, THIGHS, CHEST, AND UPPER ARMS. TOPICAL SKIN ADHESIVE WAS REMOVED FROM THE INCISIONS, THE AREA WAS WASHED WITH SOAPY WATER, AND THE PATIENT WAS STARTED ON A TOPICAL STEROID CREAM AND A COURSE OF DIPHENHYDRAMINE. WITHIN ONE WEEK OF THE EMERGENCY ROOM VISIT, THE PATIENT¿S RASH AND SYMPTOMS COMPLETELY RESOLVED AND HAVE NOT RETURNED TO DATE. THE PATIENT EXPERIENCED A DIFFUSE CUTANEOUS ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738161 DERMABOND ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention