BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 36IN 2-0 S/A CT-1

    MDR report key: 9934185 · Received April 8, 2020

    Report

    Report Number
    2210968-2020-02723
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059962
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PHM853 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED ATTEMPTS ARE BEING MADE TO RECEIVE A DEVICE FOR EVALUATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF 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. WHAT IS THE NAME OF THE INITIAL PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? DEVICE RETURN FOLLOW UP. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW#5093177.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SUTURING INCISION, THE NEEDLE BROKE IN HALF AND THE BROKEN PORTION FELL INTO SURGICAL SITE. BROKEN HALF OF NEEDLE WAS RETRIEVED FROM SURGICAL SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403105 MCRYL UD 36IN 2-0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y945H PHM853 10705031059962

    Patients

    Seq Age Sex Outcome Treatment
    1