BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT PLAIN UD 27IN USP3-0 S/A XLH

    MDR report key: 8603360 · Received May 13, 2019

    Report

    Report Number
    2210968-2019-81304
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Report Date
    April 16, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396563 GUT PLAIN UD 27IN USP3-0 S/A XLH PLAIN GUT STERILE, ABSORBABLE SURGICAL SUTURE GAL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1