BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 2032058 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00363
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    NI
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/28/2011. (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 BILATERAL INGUINAL HERNIA REPAIR AND REMOVAL OF TWO INGUINAL MASSES ON (B)(6) 2011 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT EXPERIENCED EXTREME PAIN AT THE SITES FOR FOUR DAYS. THE SURGEON PRESCRIBED LIDOCAINE GEL. ON (B)(6) 2011 THE PATIENT STATED THAT HE IS FINE AND THE ISSUE IS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention