BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM

    MDR report key: 2840511 · Received November 20, 2012

    Report

    Report Number
    2210968-2012-07513
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OMD
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2012 AND TOPICAL SKIN ADHESIVE WAS USED. THE ADHESIVE WAS REMOVED. THE PATIENT DEVELOPED RASH 5 DAYS LATER AND WAS PRESCRIBED A TOPICAL STEROID CREAM AND BENADRYL. (B)(4).

    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 THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2012 AND TOPICAL SKIN ADHESIVE WAS USED. THE TOPICAL SKIN ADHESIVE WAS LEFT ON THE WOUND FOR 2-3 WEEKS. THEN, TWO DAYS AFTER IT WAS REMOVED THE PATIENT DEVELOPED RED, CONTACT DERMATITIS. INTERVENTION INCLUDED REMOVAL OF THE ADHESIVE BECAUSE THE PATIENT WAS UNCOMFORTABLE WITH RASH AND SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT OMD ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention