BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE

    MDR report key: 19287043 · Received May 10, 2024

    Report

    Report Number
    3012164473-2024-00002
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 10, 2024
    Manufacturer
    CP MEDICAL
    Product Code
    GAP
    UDI-DI
    00889813003176
    PMA / PMN Number
    K001184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED CONCERNING PART NUMBER (B)(4). , LOT 230203-64, SIZE 4/0 SILK SWAGE SUTURE. ACCORDING TO THE REPORT, THE SUTURE DETACHED FROM THE NEEDLE DURING SURGERY. NO INJURIES OR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038518 SILK SUTURE SUTURE, NONABSORBABLE, SILK, GAP CP MEDICAL 734S-DAR 230203-64 00889813003176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other