BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    MDR report key: 4111601 · Received September 23, 2014

    Report

    Report Number
    2210968-2014-13604
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SHARD PENETRATION. CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE FOUND SHARD PENETRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LESION EXCISION ON (B)(6) 2014 AND A TOPICAL SKIN ADHESIVE WAS USED. A PIECE A GLASS HAD PROTRUDED THROUGH THE RUBBER HOUSING OF THE DEVICE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592368 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1