BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 9369038 · Received November 25, 2019

    Report

    Report Number
    2210968-2019-90269
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY ADVERSE PATIENT CONSEQUENCES? NO ADVERSE TO ANY PATIENT. IT WAS REPORTED ¿SUTURE OFTEN COMES AWAY FROM NEEDLE AT THE SWAGE¿ IF THERE WERE PREVIOUS PATIENT EVENTS WITH THIS SUTURE, WERE THEY PREVIOUSLY REPORTED: NO PREVIOUS REPORT TO JJM, CANNOT PROVIDE EXACT NUMBER OF OCCURRENCE. HAVE SPOKEN TO REPORTER TO REPORT EACH CASE TO JJM MOVING FORWARD.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE MK5059 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THERE ANY ADVERSE PATIENT CONSEQUENCES? IT WAS REPORTED ¿SUTURE OFTEN COMES AWAY FROM NEEDLE AT THE SWAGE¿? IF THERE WERE PREVIOUS PATIENT EVENTS WITH THIS SUTURE, WERE THEY PREVIOUSLY REPORTED? IF YES, PLEASE PROVIDE PC NUMBERS. IF NOT PREVIOUSLY REPORTED, PLEASE CREATE A PRODUCT COMPLAINT FOR EACH PATIENT EVENT AND INCLUDE THE FOLLOWING INFORMATION: NAME AND DATE OF PROCEDURE, EVENT DATE, EVENT DESCRIPTION, WERE THERE ANY ADVERSE PATIENT CONSEQUENCES?, PRODUCT CODE AND LOT NUMBER, IS DEVICE INVOLVED IN THE EVENT AVAILABLE FOR RETURN?.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPHTHALMIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME AWAY FROM THE NEEDLE AT THE SWAGE. A FEW DELAY TO THE PROCEDURE, AND REPLACEMENT SUTURE WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162839 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. MK5059

    Patients

    Seq Age Sex Outcome Treatment
    1