BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM

    MDR report key: 4871115 · Received June 26, 2015

    Report

    Report Number
    2210968-2015-07596
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K133864
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH GENERAL ANESTHESIA ON (B)(6) 2015 AND TOPICAL SKIN ADHESIVE WAS USED FOR BILATERAL BREAST INCISIONS. THE INCISION WAS NOT RE-PREPPED BEFORE CLOSURE AND THE DRESSING WAS NOT PLACED OVER THE INCISION. ON (B)(6) 2015 THE PATIENT EXPERIENCED A RASH AT THE SITE OF THE TOPICAL SKIN ADHESIVE. IT WAS ALSO REPORTED THAT THE REACTION AND SEVERAL HYPERPIGMENTATION OCCURRED ON BOTH BREAST SIDES. THE PATIENT DEVELOPED DARKER REDNESS WHERE THE TOPICAL SKIN ADHESIVE TAPE LAID AND AROUND BORDER REDNESS WITH SATELLITE ADHESIONS. THE TOPICAL SKIN ADHESIVE HAS BEEN REMOVED AND TOPICAL BENADRYL WAS APPLIED ANYWHERE BUT THE INCISION. NO ANOTHER METHOD WAS USED TO CLOSE THE INCISION. NO CULTURE, PATCH OR SENSITIVITY TESTS WERE PERFORMED. AS OF (B)(6) 2014, THE PATIENT¿S CURRENT STATUS IS A POST INFLAMMATORY HYPERPIGMENTATION OF THE BREAST. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. FOUR DAYS POST-OPERATIVELY, THE PATIENT EXPERIENCED A RASH AT THE SITE OF THE TOPICAL SKIN ADHESIVE. THE PATIENT UNDERWENT REMOVAL OF THE TOPICAL SKIN ADHESIVE AND WAS TREATED WITH OTC BENADRYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414831 PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT OMD ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention