BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 27IN 2-0 S/A CT-1

    MDR report key: 9334531 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90012
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 28, 2019
    Report Date
    October 28, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031060609
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TWO UNOPENED SAMPLES OF PRODUCT CODE Z339H, LOT # PGM466 WERE RETURNED FOR EVALUATION. THE COMPLAINT SAMPLE WAS NOT RETURNED. DURING THE VISUAL INSPECTION OF TWO UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE REPRESENTATIVE SAMPLES, NO BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT PGM466, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NOTE: EVENT REPORTED IN REPORTS 2210968-2019-90009, 2210968-2019-90010, 2210968-2019-90011, AND 2210968-2019-900013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REVISION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132901 PDSII VIO 27IN 2-0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. PGM466 10705031060609

    Patients

    Seq Age Sex Outcome Treatment
    1