BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 3061127 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03971
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. A SEGMENT OF SUTURE WAS PROTUDING FROM UNDERNEATH THE PAPER COVER AND EXTENDING AWAY FROM THE TRAY. THE SUTURE SEGMENT EXTENDED TO THE SEAL AREA AND WAS CAUGHT IN THE CHEVRON PORTION OF THE SEAL. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): 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 ON (B)(6) 2013, THE END OF THE SUTURE HAD BEEN CAUGHT IN THE TYVEK SEAL AREA BEFORE USE. THE PRODUCT WAS NOT USED ON A PATIENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163886 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA EHE521

    Patients

    Seq Age Sex Outcome Treatment
    1