BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLU 75CM M0.7

    MDR report key: 8778267 · Received July 10, 2019

    Report

    Report Number
    2210968-2019-83879
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    January 1, 2018
    Report Date
    June 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 09/18/2019. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE ADVISE IF THE KNOTS CAME UNDONE DURING THE INITIAL PROCEDURE? UNK. DID THE SURGEON RE-SUTURE PATIENT IN SAME INITIAL PROCEDURE? UNK. WHAT IS THE CONDITION OF THE PATIENT? GOOD, NO PATIENT CONSEQUENCE. A FIRST MERSILENE DEVICE WAS USED AND ITS NEEDLE PULLED OFF. THEN, THE SURGEON TOOK A SECOND MERSILENE DEVICE AND ITS NEEDLE ALSO PULLED OFF. SO, THE SURGEON TOOK ANOTHER DEVICE FROM ANOTHER BRAND TO COMPLETE THE PROCEDURE. MERSILENE DEVICES REPORTED IN 2210968-2019-87845 AND 2210968-2019-87846.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 07/17/2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH LPJ202, F181119 AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. PLEASE ADVISE IF THE KNOTS CAME UNDONE DURING THE INITIAL PROCEDURE? DID THE SURGEON RE-SUTURE PATIENT IN SAME INITIAL PROCEDURE? WHAT IS THE CONDITION OF THE PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL AXILLARY BYPASS PROCEDURE ON UNKNOWN DATE IN 2018 AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE THREAD. THE ANASTOMOSIS HAS BEEN UNDONE AND ANOTHER DEVICE WAS USED TO RESEW THE ANASTOMOSIS AND COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569456 PROLENE BLU 75CM M0.7 SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. LPJ202

    Patients

    Seq Age Sex Outcome Treatment
    1