BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 18IN 5-0 S/A P-3 PRM MP

    MDR report key: 7522771 · Received May 17, 2018

    Report

    Report Number
    2210968-2018-72872
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059252
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: (B)(4) 2018. A DETACHED NEEDLE, A DISPENSED SUTURE, A LABELED WINDING FORMER AND ONE EMPTY OPENED FOIL WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE NEEDLE THE SWAGE AND ATTACHMENT AREA WERE AS EXPECTED. THE BARREL HOLE OF THE NEEDLE WAS EXAMINED UNDER 20X MAGNIFICATION AND NO SUTURE REMNANT WAS NOTED. THE SUTURE WAS EXAMINED AND THE INSERTION END WAS MEASURED AND DID NOT MEET THE REQUIREMENT. PER THE SAMPLE CONDITION, THE ASSIGNABLE CAUSE OF THE PERFORMANCE - PULL OFF SUTURE NEEDLE IS A SHORT INSERTION. THIS DEFECT IS CAUSED BECAUSE THE INSERTION OF THE SUTURE IN THE NEEDLE WAS INSUFFICIENT FROM KEEP THE NEEDLE/SUTURE UNION DURING TRANSPORTATION OR USE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF DURING A SIMPLE INTERRUPTED SUTURE LINE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365228 MCRYL VIO 18IN 5-0 S/A P-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. LJM509 10705031059252

    Patients

    Seq Age Sex Outcome Treatment
    1