BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9988268 · Received April 22, 2020

    Report

    Report Number
    2951250-2020-05147
    Event Type
    Injury
    Date Received
    April 22, 2020
    Report Date
    May 6, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    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 DEVICE BREAKAGE ('DOCTOR LEFT PIECES OF THE COIL BEHIND AND THEY ARE EMBEDDED IN THE UTERUS'), EMBEDDED DEVICE ('DOCTOR LEFT PIECES OF THE COIL BEHIND AND THEY ARE EMBEDDED IN THE UTERUS'), CHOLECYSTECTOMY ('GALLBLADDER REMOVAL') AND SYNCOPE ('PASSED OUT IN A PARKING LOT FROM THE INTENSE PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE." ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE REMOVAL ("DOCTOR LEFT PIECES OF THE COIL BEHIND AND THEY ARE EMBEDDED IN THE UTERUS"), SYNCOPE (SERIOUSNESS CRITERION HOSPITALIZATION) AND DYSMENORRHOEA ("A LOT OF PAIN AROUND MY CYCLES SINCE REMOVAL OF ESSURE"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH ESSURE") AND UNDERWENT CHOLECYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND SYNCOPE HAD RESOLVED AND THE CHOLECYSTECTOMY, COMPLICATION OF DEVICE REMOVAL AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE REPORTER CONSIDERED CHOLECYSTECTOMY, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, DYSMENORRHOEA, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND SYNCOPE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I HAD MY TUBES AND ESSURE REMOVED 2 YEARS AGO AFTER THE BIRTH OF MY E -BABY. I HAVE EXPERIENCED A LOT OF PAIN AROUND MY CYCLES SINCE. TONGHT I PASSED OUT IN A PARKING LOT FROM THE INTENSE PAIN. FRIENDS GOT ME TO THE HOSPITAL. TESTS SHOWED THAT THE DOCTOR LEFT PIECES OF THE COILS BEHIND AND THEY ARE EMBEDDED IN THE UTERUS. A HYSTERECTOMY WAS DONE. I HAVE PREVIOUSLY BEEN TOLD I HAD PMDD AND THAT´S WHY THE PAIN BEFORE MY CYCLES WAS SO SEVERE. IN MAY GALLBLADDER REMOVAL WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: PIECES OF ESSURE IN THE UTERUS. ULTRASOUND SCAN - ON AN UNKNOWN DATE: PIECES OF ESSURE IN THE UTERUS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAY-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 DEVICE BREAKAGE ('DOCTOR LEFT PIECES OF THE COIL BEHIND AND THEY ARE EMBEDDED IN THE UTERUS'), EMBEDDED DEVICE ('DOCTOR LEFT PIECES OF THE COIL BEHIND AND THEY ARE EMBEDDED IN THE UTERUS'), CHOLECYSTECTOMY ('GALLBLADDER REMOVAL') AND SYNCOPE ('PASSED OUT IN A PARKING LOT FROM THE INTENSE PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE REMOVAL ("DOCTOR LEFT PIECES OF THE COIL BEHIND AND THEY ARE EMBEDDED IN THE UTERUS"), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SYNCOPE (SERIOUSNESS CRITERION HOSPITALIZATION) AND DYSMENORRHOEA ("A LOT OF PAIN AROUND MY CYCLES SINCE REMOVAL OF ESSURE"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH ESSURE") AND UNDERWENT CHOLECYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE COMPLICATION OF DEVICE REMOVAL, CHOLECYSTECTOMY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND SYNCOPE HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE REPORTER CONSIDERED CHOLECYSTECTOMY, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, DYSMENORRHOEA, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND SYNCOPE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I HAD MY TUBES AND ESSURE REMOVED 2 YEARS AGO AFTER THE BIRTH OF MY E -BABY. I HAVE EXPERIENCED A LOT OF PAIN AROUND MY CYCLES SINCE. TONIGHT I PASSED OUT IN A PARKING LOT FROM THE INTENSE PAIN. FRIENDS GOT ME TO THE HOSPITAL. TESTS SHOWED THAT THE DOCTOR LEFT PIECES OF THE COILS BEHIND AND THEY ARE EMBEDDED IN THE UTERUS. A HYSTERECTOMY WAS DONE. I HAVE PREVIOUSLY BEEN TOLD I HAD PMDD AND THAT´S WHY THE PAIN BEFORE MY CYCLES WAS SO SEVERE. IN MAY GALLBLADDER REMOVAL WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: PIECES OF ESSURE IN THE UTERUS. ULTRASOUND SCAN - ON AN UNKNOWN DATE: PIECES OF ESSURE IN THE UTERUS. 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
    450467 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R