BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10017558 · Received May 1, 2020

    Report

    Report Number
    2951250-2020-06421
    Event Type
    Injury
    Date Received
    May 1, 2020
    Report Date
    May 6, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MULTIPLE ALLERGIES ('INSIDE ALLERGIES') AND SEASONAL ALLERGY ('SEASONAL ALLERGIES') IN A FEMALE INFANT WHOSE PARENT HAD INSERTED ESSURE AT THE TIME OF CONCEPTION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: EXPOSURE VIA BREAST MILK "EXPOSURE VIA BREASTMILK" FROM (B)(6) 2010 TO (B)(6) 2010. THE INFANT'S FAMILY HISTORY INCLUDED SEASONAL ALLERGY (VERY COMMON IN FAMILY) AND MULTIPLE ALLERGIES (INSIDE, VERY COMMON IN FAMILY). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PARENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE INFANT WAS DIAGNOSED WITH SEASONAL ALLERGY AND MULTIPLE ALLERGIES. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE SEASONAL ALLERGY AND MULTIPLE ALLERGIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MULTIPLE ALLERGIES AND SEASONAL ALLERGY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED IN MOTHER (US-BAYER-2013-132655) WHEN THIS FEMALE DAUGHTER WAS 6 MONTHS OLD AND BREASTFED UNTIL SHE WAS 15 MONTHS OLD. SHE HAS NO ISSUES BESIDES SEASONAL AND INSIDE ALLERGIES (VERY COMMON IN MOTHER'S FAMILY). MOTHER LATER HAD A FEMALE BABY CONCEIVED UNDER ESSURE AND BREASTFED (SEE US-BAYER-2020-069354), WHO HAD SEASONAL ALLERGIES AND HYPOTHYROIDISM QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS REPORT REFERS TO PATIENT'S FIRST BREASTFED BABY UNDER ESSURE (NOT CONCEIVED UNDER ESSURE). THE RETAINED EVENT WAS SEASONAL ALLERGY, EVENT ADDED: INSIDE ALLERGIES, EXPOSURE VIA BREASTMILK. FAMILY HISTORY INCLUDED SEASONAL ALLERGY, INSIDE ALLERGIES. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF SEASONAL ALLERGY ('SEASONAL ALLERGIES'), BREAST FEEDING ('BREAST FEEDING') AND HYPOTHYROIDISM ('SHE WAS DIAGNOSED WITH HYPOTHYROIDISM AT (B)(6) OLD') IN A FEMALE PATIENT WHOSE PARENT HAD INSERTED ESSURE AT THE TIME OF CONCEPTION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: FOETAL EXPOSURE DURING PREGNANCY "FETAL EXPOSURE DURING PREGNANCY" (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PARENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH SEASONAL ALLERGY, BREAST FEEDING AND HYPOTHYROIDISM. AT THE TIME OF THE REPORT, THE SEASONAL ALLERGY AND HYPOTHYROIDISM OUTCOME WAS UNKNOWN AND THE BREAST FEEDING HAD RESOLVED. THE REPORTER CONSIDERED BREAST FEEDING, HYPOTHYROIDISM AND SEASONAL ALLERGY TO BE RELATED TO ESSURE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481306 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other