BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED

    MDR report key: 3123969 · Received May 22, 2013

    Report

    Report Number
    2210968-2013-05775
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) - SHARD PENETRATION. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND TOPICAL SKIN ADHESIVE WAS USED. WHEN ATTEMPTING TO DISPENSE THE PRODUCT, GLASS SHATTERED INSIDE PEN AND BROKE THROUGH THE AMPOULE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226129 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE MPN ETHICON, INC. NA EGB468

    Patients

    Seq Age Sex Outcome Treatment
    1