BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    MDR report key: 3900282 · Received June 27, 2014

    Report

    Report Number
    2210968-2014-08368
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 9, 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). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE REVEALED A PIERCING THROUGH WHICH A GLASS SHARD PROTRUDED IN THE APPLICATOR BULB. ALSO, A PIERCING IN THE BUTYRATE TUBE IS OBSERVED. THESE PIERCINGS COINCIDE IN POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2014 AND A TOPICAL SKIN ADHESIVE WAS USED. PRIOR TO THE PROCEDURE, THE ASSISTANT CRACKED THE ADHESIVE APPLICATOR AND THE INSIDE AMPOULE OF LIQUID BROKE BUT A PIECE OF GLASS WENT THROUGH THE RUBBER AND POKED HER. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376826 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1