BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMD-RITMED LAPAROTOMY SPONGE

    MDR report key: 10706696 · Received October 20, 2020

    Report

    Report Number
    9611959-2020-00003
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    August 24, 2020
    Report Date
    August 28, 2020
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    GDY
    UDI-DI
    20686864045216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED. A PROBABLE CAUSE IS ATTRIBUTED TO THE USE OF THE DEVICE WITH THE TWEEZERS TIP WHICH IS SHARP WITH BURRS AND SCRAPING THE SPONGES WHICH GENERATED FIBERS. PERSONNEL ARE RETRAINED ON THE STAGES OF THE MANUFACTURING PROCESS TO ENSURE THE PRODUCTION PROCESS STAYS UNDER CONTROL.

    Description of Event or Problem · 0

    A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON 28-AUG-2020 FOR AMD-RITMED LAPAROTOMY SPONGE ITEM CODE 1501-ROLL LOT# 81043-1. THE LAPAROTOMY SPONGE IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE GDY. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED "LINT ON OVERHEAD TABLE COVER AND INSTRUMENTS. LINT ON LIVER DURING PROCEDURE" THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON 28-AUG-2020 FOR AMD-RITMED LAPAROTOMY SPONGE ITEM CODE1501-ROLL LOT# 81043-1. THE LAPAROTOMY SPONGE IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE GDY. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED "LINT ON OVERHEAD TABLE COVER AND INSTRUMENTS. LINT ON LIVER DURING PROCEDURE" THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173952 AMD-RITMED LAPAROTOMY SPONGE LAPAROTOMY SPONGE GDY AMD MEDICOM INC. 1501-ROLL 81043-1 20686864045216

    Patients

    Seq Age Sex Outcome Treatment
    1