BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND MINI

    MDR report key: 3023601 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02874
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2013-02871, 2210968-2013-02872, AND 2210968-2013-02873. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE SAMPLE WAS VISUALLY EXAMINED AND THE PACKAGE SHOWS THAT THE STERILE SEAL IT¿S INTACT. THE HEAT SEAL COATED FROM THE TYVEK IS OBSERVED TRANSFERRED AND CONTINUOUS AROUND THE BLISTERS (NO FADING, WRINKLES, CHANNELS, CUTOFF OR VOIDS). ALSO, THE PACKAGE WAS MEASURED FOR SEAL WIDTH AND THE BLISTER WAS WITHIN REQUIREMENTS. (B)(4): REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE UNOPENED BLISTER SHOWS THAT PACKAGE IS CLOSED AND SEALED. NO DAMAGES OR DEFECTS ARE OBSERVED. HOWEVER, A BROKEN AMPOULE IS OBSERVED ON THE APPLICATOR INSIDE THE PACKAGE. DRIED FORMULATION IS SEEN ON THE BOTTOM OF THE APPLICATOR. BUT, THE FILTER INSIDE THE TIP IS WHITE IN COLOR INDICATING THAT THE FORMULATION WAS NOT DISPENSED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DEALER THAT THE BLISTER POUCH WAS OPENED. THIS DID NOT OCCUR DURING A PROCEDURE. THEREFORE, THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126234 DERMABOND MINI ADHESIVE, TOPICAL SKIN MPN ETHICON, INC. NA EHB150

    Patients

    Seq Age Sex Outcome Treatment
    1