BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 3222400 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-12917
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/02/2013. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE APPLICATOR REVEALS A GLASS SHARD THAT PROTRUDED IN THE BUTYRATE TUBE. THE GLASS SHARD IS OBSERVED COMING OUT OF THE BUTYRATE TUBE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND TOPICAL SKIN ADHESIVE WAS USED. DURING USE, THE SURGEON PRESSED THE AMPOULE OF THE DEVICE AND GLASS SHARDS CAME THROUGH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324220 DERMABOND TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK GDB323

    Patients

    Seq Age Sex Outcome Treatment
    1