BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL UD 27IN USP5-0

    MDR report key: 8875484 · Received August 8, 2019

    Report

    Report Number
    2210968-2019-85316
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 12, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEVICE EVALUATION SUMMARY: IT WAS RECEIVED FOR ANALYSIS AN OPENED BOX WITH SEVENTEEN UNOPENED SAMPLES OF PRODUCT CODE C389, LOT ML6955. DURING THE VISUAL INSPECTION OF THIRTEEN 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 STRANDS AND NO DEFECTS, OR DAMAGED WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE WERE ABOVE THE MINIMUM REQUIREMENTS. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/ PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE SAMPLE RECEIVED, NO PERFORMANCE PULL OFF SUTURE NEEDLE WAS FOUND, AND THE TESTED SAMPLE MET THE FINISHED GOODS REQUIREMENTS. REPRESENTATIVE SAMPLES RETURNED TO SUPPORT INVESTIGATION OF 3 DEVICE ISSUES CAPTURED IN REPORTS 2210968-2019-83881, 2210968-2019-83882 AND 2210968-2019-85316. ANALYSIS RESULTS HAVE BEEN INCLUDED IN FOLLOW-UP REPORTS FOR EACH.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, IT WAS REPORTED THE NEEDLE THAT PULLED FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669638 MONOCRYL UD 27IN USP5-0 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. ML6955

    Patients

    Seq Age Sex Outcome Treatment
    1