BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT PL UD 27IN 5-0 S/A FS-2

    MDR report key: 18817202 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02189
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    UDI-DI
    10705031037762
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED LATER A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. RELATED REPORTS: MANUFACTURING REPORT # 2210968-2024-02190 ; 2210968-2024-02188 .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING SURGERY, THAT THEY HAD AN ISSUE WITH A SUTURE POPPING OFF FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001107 GUT PL UD 27IN 5-0 S/A FS-2 SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC. TDMAER 10705031037762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown