BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PROPEN

    MDR report key: 2021295 · Received March 7, 2011

    Report

    Report Number
    2210968-2011-00234
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A DIAPHRAGMATIC PLYCATION PROCEDURE ON (B)(6) 2011 AND TOPICAL SKIN ADHESIVE WAS USED. WITHIN 24 HOURS, THE PT HAD BLISTERS AS WELL AS RASHES AT SEVEN PORT SITES AND ONE SITE WHERE THE ADHESIVE HAD DRIPPED ON TO THE PT. THE RASHES EXTENDED ABOUT 2-3 INCHES FROM PORT SITES. THE SURGEON STATED THAT THE SURGEON DID NOT REMOVE THE TOPICAL SKIN ADHESIVE BECAUSE THE SURGEON DID NOT WANT THE SITES TO OPEN. THE LEFT LATERAL CHEST SITE BECAME INFECTED. THE PT WAS TREATED WITH ATARAX AND TRIAMCINOLONE. CURRENTLY, THE PT'S BLISTERS ARE GONE AND THE RASH IS ALMOST GONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention