BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 12745913 · Received November 3, 2021

    Report

    Report Number
    2210968-2021-10765
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    May 2, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE: WHAT IS THE PRODUCT CODE? ACCORDING TO THE FEEDBACK OF THE SALES REPRESENTATIVE, ALL THE ABOVE ANSWERS ARE UNKNOWN. WHAT IS THE LOT NUMBER? 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. EVENTS REPORTED VIA: 2210968-2021-10764 AND 2210968-2021-10766.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANORECTAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647019 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1