BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL VIO 27IN USP5-0::S/A BB PLUS VB

    MDR report key: 8030471 · Received November 1, 2018

    Report

    Report Number
    2210968-2018-76891
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Report Date
    October 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    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 FDA: 3/21/2019. ADDITIONAL EVALUATION SUMMARY: TWO NEEDLE/SUTURE PIECES AND TWO SUTURE PIECES OF PRODUCT CODE C2023, LOT # MBM881 WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE TWO SAMPLES, THE SUTURE PIECES HAVE BEGUN WITH THE PROCESS OF DISINTEGRATION, SINCE THE SUTURES WERE BROKEN IN HANDLING OF THE SAMPLES. THE PRODUCT CODE C2023 CONTAINS AN ABSORBABLE SUTURE AND AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE OF SUTURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND NO FUNCTIONAL TEST CAN BE PERFORMED DUE TO SAMPLE CONDITION. ALSO, THE FOIL WAS EXAMINED AND NO DAMAGES OR DEFECTS WERE NOTED. DUE TO CONDITION OF THE SAMPLE RECEIVED, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 A PATIENT UNDERWENT A DENTAL IMPLANT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD BROKE WHEN MAKING THE KNOT. A NEW SUTURE WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868950 MONOCRYL VIO 27IN USP5-0::S/A BB PLUS VB SUTURE, SURGICAL, ABSORBABLE GAN ETHICON INC. MBM881

    Patients

    Seq Age Sex Outcome Treatment
    1