BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SURGIPOINT

    MDR report key: 12044751 · Received June 22, 2021

    Report

    Report Number
    3006981798-2021-00006
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAM
    UDI-DI
    00812444020250
    PMA / PMN Number
    K120556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THE REPORTER COULD NOT IDENTIFY THE LOT NUMBER FOR THE PRODUCT BUT INDICATED THAT IT WAS ONE OF TWO POSSIBLE LOT NUMBERS (LOT 20082511; 20113003). RETAINS FROM BOTH LOT NUMBERS PROVIDED WERE TESTED FOR FINISHED GOODS TESTING, INCLUDING NEEDLE ATTACHMENT AND TENSILE STRENGTH TESTING. ALL SAMPLES TESTED PASSED. A CAUSE OF THE EVENT COULD NOT BE ESTABLISHED AND THE REPORT COULD NOT BE SUBSTANTIATED. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL LLC REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, "THE NEEDLE SEPARATED FROM THE THREAD. THE DOCTOR DISPOSED OF THE DEFECTIVE SUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936232 SURGIPOINT SUTURE GAM RIVERPOINT MEDICAL LLC LV-493B 20082511 00812444020250

    Patients

    Seq Age Sex Outcome Treatment
    1