BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 3073199 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04329
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 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

    DATE SENT TO THE FDA: 06/12/2013.CONCLUSION: LOOSE SUTURE WAS MICROSCOPICALLY EXAMINED, DENTS WERE FOUND THROUGH ALL THE SUTURE AND MEMORY WAS FOUND CAUSED BY THE STRETCHING OF THE SUTURE. DENTS APPEAR TO BE CAUSED DURING HANDLING. FORCE AND TECHNIQUE USE CAN CAUSE SUTURE STRETCH RESULTING IN MEMORY. ROOT CAUSE CANNOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 SUTURE WAS USED. WHEN THE SURGEON WAS DISPENSING THE PRODUCT, IT WAS NOTED THAT THE SUTURE WAS KINKED. A LIKE DEVICE WAS USED TO COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175611 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA EHE209

    Patients

    Seq Age Sex Outcome Treatment
    1