BEUDAMED
    FDA Adverse Event Other Summary report: N

    S ALEXIS WND PROT/RET 5/BX

    MDR report key: 3471708 · Received November 1, 2013

    Report

    Report Number
    2027111-2013-00454
    Event Type
    Other
    Date Received
    November 1, 2013
    Date of Event
    November 1, 2012
    Report Date
    October 23, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO MFR. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56 IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    URETEROVESICOSTOMY - "THE PATIENT WAS (B)(6) OLD. WEIGHT: (B)(6) KG. HEIGHT: (B)(6). SEX: (B)(6). THE FLUCTUATION OF BLOOD PRESSURE: PRE USAGE - 80/30, POST 40/A4. INCISION SIZE: 3 CM (LOWER UMBILICUS), GENERAL ANESTHESIA WAS CONDUCTED DR (B)(6) OF (B)(6) CHILDREN'S MEDICAL CENTER REPORTED THAT THE BLOOD PRESSURE REDUCTION OCCURRED BY USING ALEXIS. AFTER TAKING OFF THE ALEXIS, THE BLOOD PRESSURE ROSE QUICKLY. NO SSI OCCURRED AFTER THE SURGERY. NO SYMPTOMS OTHER THAN THE BLOOD PRESSURE REDUCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562951 S ALEXIS WND PROT/RET 5/BX ALEXIS GCJ APPLIED MEDICAL C8301 NOT SURE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other