BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE

    MDR report key: 3873848 · Received June 9, 2014

    Report

    Report Number
    3005345832-2014-00005
    Event Type
    Death
    Date Received
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    AMNISURE INTERNATIONAL, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS EVALUATED THIS EVENT AND HAS DETERMINED THAT THE RESULT OBTAINED FROM THE DEVICE DID NOT CONTRIBUTE OR CAUSE TO THE DEATH OF THE FETUS. HOWEVER, THE COMPANY HAS DECIDED TO SUBMIT THIS MDR FOR INFO PURPOSES IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFO, AS NECESSARY. THE HEALTHCARE FACILITY REPORTED UNEXPECTED NEGATIVE RESULTS. THE ROOT CAUSE FOR THESE RESULTS IN UNDETERMINED HOWEVER, THE AMNISURE PRODUCT INSTRUCTIONS FOR USE RECOMMENDS THAT RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFO. FAILURE TO DETECT MEMBRANE RUPTURE DOES NOT ASSURE THE ABSENCE OF MEMBRANE RUPTURE.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON (B)(4) 2013 REGARDING A PT WHO WAS AT 23 WEEKS GESTATION AND HAD BEEN INFERTILE FOR 10 YEARS. SHE PRESENTED WITH LEAKAGE AND WAS TESTED WITHIN 12 HOURS. THE AMNISURE TEST WAS NEGATIVE. SHE WAS DISCHARGED. PT RETURNED 24 HOURS LATER AND THE FETUS HAD EXPIRED. AMNIOTIC FLUID WAS CULTURED AND BACTERIA WERE PRESENT. NO GROSS RUPTURE WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335303 AMNISURE RAPID FETAL MEMBRANE RUPTURE TEST NQM AMNISURE INTERNATIONAL, LLC FMRT-1 A2019

    Patients

    Seq Age Sex Outcome Treatment
    1 Death