BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G6313, L ALEXIS O C-SEC RET 5/BX

    MDR report key: 7049734 · Received November 21, 2017

    Report

    Report Number
    2027111-2017-02120
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 25, 2017
    Report Date
    December 20, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915118129
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT. HOWEVER, THE COMPLAINANT'S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED AND THERE WERE NO VISIBLE NON-CONFORMANCES. WHEN THE INNER RING WAS COMPRESSED, IT RETURNED TO ITS ORIGINAL CIRCULAR SHAPE WHEN IT WAS RELEASED. ALTHOUGH THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Additional Manufacturer Narrative · 1

    APPLIED MEDICAL HAS JUST RECEIVED THE EVENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED - LOWER SEGMENT CAESAREAN SECTION. INCISION SIZE MEASURED- 12.5 CM. ALEXIS INSERTED AND ROLLED DOWN. YELLOW PLACEMENT RING WAS FOLDED INWARDS, OBSTRUCTING THE OPERATING FIELD. WHILST BABY WAS DELIVERED, ALEXIS CAME OUT OF SITU. WHEN REINSERTING ALEXIS O C SECTION, IT WOULD NOT STAY IN PLACE. ANOTHER ALEXIS O C SECTION WAS USED. TYPE OF INTERVENTION - ANOTHER ALEXIS O C SECTION WAS USED. PATIENT STATUS -DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827569 G6313, L ALEXIS O C-SEC RET 5/BX KGW KGW APPLIED MEDICAL RESOURCES G6313 1298996 00607915118129

    Patients

    Seq Age Sex Outcome Treatment
    1