BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDGYN LAMINARIA

    MDR report key: 1395953 · Received May 22, 2009

    Report

    Report Number
    1450908-2009-00001
    Event Type
    Injury
    Date Received
    May 22, 2009
    Date of Event
    April 21, 2009
    Report Date
    May 22, 2009
    Manufacturer
    MEDGYN PRODUCTS, INC.
    Product Code
    HDY
    PMA / PMN Number
    880196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NO INFO ON WHO USED THE PRODUCT, WHICH SIZE OF LAMINARIA, OR WHICH LOT NUMBER OF LAMINARIA WAS USED ON THE PT. WE WERE NOT INFORMED WHO FILED THE REPORT, WHO THE USER PHYSICIAN WAS, OR IN WHICH CITY OR COUNTRY THE INCIDENT OCCURRED. THE PRODUCT DID NOT COME BACK TO US, AND THERE IS NO FOLLOW UP INVESTIGATION WHICH WE CAN CARRY OUT. WE HAVE NEVER HAD SUCH BRADYCARDIA AND BLOOD PRESSURE EFFECT REPORTED TO US IN THE PAST. THIS INCIDENT IS THE FIRST REPORT OF THIS TYPE OF HEART RATE AND BLOOD PRESSURE EFFECT WE HAVE COME ACROSS.

    Description of Event or Problem · 1

    MEDGYN PRODUCTS, INC. DID NOT RECEIVE A REPORT ABOUT THE INCIDENT FROM THE END USER, THE ONLY INFO WE HAVE IS FROM THE REPORT FDA SENT TO US. A PT WAS GIVEN PERACERVICAL LIDOCAINE 1% 10 ML, AND THEN 7 LAMINARIA WERE INSERTED. PT HAD ABDOMINAL CRAMPING AND FELT LIGHT HEADED, DIZZY, AND THIRSTY. FIVE MINUTES AFTER INSERTION, BLOOD PRESSURE AND HEART RATE DROPPED FROM 107/64; 82 TO 94/59; 67. PT WAS MONITORED, BUT THERE WAS NO IMPROVEMENT. PT WAS GIVEN ATROPINE 1 MG IV AND PERCOCET 5/235 MG X 1. BLOOD PRESSURE AND HEART RATE IMPROVED WITH RECURRENCE OF BRADYCARDIA AND HYPOTENSION. PT WAS ADMITTED TO A HOSPITAL FOR OBSERVATION AND HAD HER PROCEDURE PERFORMED THE NEXT DAY AS SCHEDULED. WE FOUND OUT FROM FDA LETTER. IDENTITY OF INITIAL REPORTER NOT REVEALED TO US BY FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDGYN LAMINARIA HDY HYGROSCOPIC LAMINARIA CERVICAL DILATOR HDY MEDGYN PRODUCTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization PERACERVICAL LIDOCAINE 1% 10 ML