BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8030118 · Received November 1, 2018

    Report

    Report Number
    2951250-2018-04534
    Event Type
    Injury
    Date Received
    November 1, 2018
    Report Date
    July 15, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF LOW BIRTH WEIGHT BABY ('BIRTH WEIGHT 4 POUNDS 4 OUNCES') IN A FEMALE INFANT WHOSE MOTHER HAD INSERTED ESSURE (BATCH NO. 802744) DURING PREGNANCY. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: FOETAL EXPOSURE DURING PREGNANCY "FETAL EXPOSURE DURING PREGNANCY". THE MOTHER'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6)2000, (B)(6)2009, (B)(6)2011, (B)(6)2012) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED HYPOKALEMIA SINCE (B)(6)2015, DIARRHEA SINCE (B)(6)2015, VAGINAL DISCHARGE SINCE (B)(6)2011, CANDIDIASIS SINCE (B)(6)2011, BODY MASS INDEX NORMAL AND ANXIETY. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT. THE INFANT'S MOTHER WAS EXPOSED TO ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6)2012. 1899.03G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). ON AN UNKNOWN DATE, THE 33-YEAR-OLD MOTHER (GRAVIDA 8, PARA 5) HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE INFANT WAS DIAGNOSED WITH LOW BIRTH WEIGHT BABY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). AT THE TIME OF THE REPORT, THE LOW BIRTH WEIGHT BABY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED LOW BIRTH WEIGHT BABY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LAST DELIVERY WAS EMERGENCY C-SECTION DUE TO MY PLACENTA TEARING OFF THE WALL AND STARTED BLEEDING, HAD BALL BLOOD CLOTS; MY BABY WAS BORN 32 WEEKS. DID YOU EXPERIENCE COMPLICATIONS OF UNINTENDED PREGNANCY? YES. PRE-TERM LABOR, PREMATURE DELIVERY, CAESAREAN SECTION, OTHER (PLEASE DESCRIBE) BABY STAYED IN HOSPITAL FOR 5 WEEKS DUE TO NOT EATING, STAYED IN INCUBATOR FOR 4 WEEKS WITH BREATHING TUBE THROUGH BELLY BUTTON BECAUSE VEINS WERE TOO SMALL IN BABY¿S HEAD. BIRTH WEIGHT 4 LBS. DO YOU ALLEGE BIRTH DEFECTS? NO. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUN-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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 LOW BIRTH WEIGHT BABY ("BIRTH WEIGHT 4 POUNDS 4 OUNCES") IN A FEMALE INFANT EXPOSED TO ESSURE (BATCH NO. 802744) DURING PREGNANCY. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: FOETAL EXPOSURE DURING PREGNANCY "FETAL EXPOSURE DURING PREGNANCY". THE MOTHER'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2000, (B)(6) 2009, (B)(6) 2011, (B)(6) 2012) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, VAGINAL DISCHARGE SINCE (B)(6) 2011, CANDIDIASIS SINCE (B)(6) 2011, HYPOKALEMIA SINCE (B)(6) 2015, DIARRHEA SINCE (B)(6) 2015 AND ANXIETY. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT ON (B)(6) 2012. ON AN UNKNOWN DATE, THE MOTHER HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE INFANT WAS DIAGNOSED WITH LOW BIRTH WEIGHT BABY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE INFANT WAS EXPOSED TO ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. AT THE TIME OF THE REPORT, THE LOW BIRTH WEIGHT BABY OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2012. (B)(6) WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). THE REPORTER CONSIDERED LOW BIRTH WEIGHT BABY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LAST DELIVERY WAS EMERGENCY C-SECTION DUE TO MY PLACENTA TEARING OFF THE WALL AND STARTED BLEEDING, HAD BALL BLOOD CLOTS; MY BABY WAS BORN 32 WEEKS. DID YOU EXPERIENCE COMPLICATIONS OF UNINTENDED PREGNANCY? YES. PRE-TERM LABOR, PREMATURE DELIVERY, CAESAREAN SECTION, OTHER (PLEASE DESCRIBE) BABY STAYED IN HOSPITAL FOR 5 WEEKS DUE TO NOT EATING, STAYED IN INCUBATOR FOR 4 WEEKS WITH BREATHING TUBE THROUGH BELLY BUTTON BECAUSE VEINS WERE TOO SMALL IN BABY'S HEAD. BIRTH WEIGHT (B)(6). DO YOU ALLEGE BIRTH DEFECTS? NO. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-NOV-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. ON 1-NOV-2018: UPON ROUTINE MONITORING QUALITY ACTIVITY, CAUSALITY ASSESSMENT FOR LOW BIRTH WEIGHT BABY WAS AMENDED FROM UNRELATED TO RELATED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869137 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 802744 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other