BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON BLUE 4.0M 2M W/NDL

    MDR report key: 7738798 · Received August 1, 2018

    Report

    Report Number
    2210968-2018-74799
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. 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 CLARIFY WHEN THE SUTURE BROKE: - WHILE IN THE PACKAGE , - WHEN REMOVING FROM THE PACKAGE , - DURING USE ON PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. BOTH PARTS OF THE SUTURE WERE RECOVERED AND THE PATIENT WAS NOT AFFECTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580543 ETHILON BLUE 4.0M 2M W/NDL SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. MBK343

    Patients

    Seq Age Sex Outcome Treatment
    1