BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP

    MDR report key: 17547386 · Received August 14, 2023

    Report

    Report Number
    2210968-2023-05888
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    January 1, 2023
    Report Date
    September 7, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039773
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SCRUB TECH HANDED SUTURE TO SURGEON FOR SURGEON TO CLOSE SKIN. SURGEON STARTED TO USE SUTURE. WHEN SUTURE WAS PULLED THROUGH, PART OF THE STRING OF THE SUTURE FELL OFF FROM THE REST. SURGEON NOTIFIED SCRUB TECH WHO NOTIFIED CIRCULATOR AND MANAGEMENT. SUTURES WITH SAME LOT NUMBER TAKEN OFF SHELF IN SET-UPS, MANAGER OF SET-UPS NOTIFIED ALSO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792381 VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. TEMKSE 10705031039773

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown