BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    MDR report key: 3190454 · Received June 26, 2013

    Report

    Report Number
    1527736-2013-00028
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. 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. 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 A CABG PROCEDURE ON (B)(6) 2013 AND TOPICAL SKIN ADHESIVE WAS USED. DURING THE PROCEDURE, THE PA CRACKED OPEN THE TOPICAL SKIN ADHESIVE AND THE GLASS WENT THROUGH THE RUBBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291223 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON ENDO SURGERY, INC (CINCINNATI) UNK GDE164

    Patients

    Seq Age Sex Outcome Treatment
    1