BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 4093297 · Received September 16, 2014

    Report

    Report Number
    2210968-2014-12892
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 PATIENT UNDERWENT A LAPAROSCOPIC TUBAL LIGATION PROCEDURE BECAUSE SHE DESIRED STERILIZATION ON (B)(6) 2014 AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE SITES. CHLORAPREP WAS USED ON THE SKIN. PRIOR TO CLOSURE, THE SKIN WAS WIPED WITH WATER, DRIED WITH A TOWEL AND THEN THE TOPICAL SKIN ADHESIVE WAS APPLIED. THE PATIENT WAS DISCHARGED AND LATER REPORTED ONE ABDOMINAL PORT SITE OPENED LESS THAT 1 INCH IN SIZE BY THE NEXT MORNING. THE PATIENT WAS SEEN AND ADDITIONAL TOPICAL SKIN ADHESIVE WAS APPLIED TO THE WOUND ALONG WITH STERI-STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570908 DERMABOND TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention