BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9097693 · Received September 20, 2019

    Report

    Report Number
    2951250-2019-07537
    Event Type
    Injury
    Date Received
    September 20, 2019
    Report Date
    May 22, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION: YES.'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: STILLBIRTH/MISCARRIAGE') AND ABORTION SPONTANEOUS ('PREGNANCY: STILLBIRTH/MISCARRIAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C51076) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING),"), PELVIC PAIN ("PELVIC/ABDOMINAL PAIN"), ABDOMINAL PAIN ("PELVIC/ABDOMINAL PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING"), ALOPECIA ("HAIR LOSS.") AND FATIGUE ("FATIGUE,") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, BACK PAIN, DYSMENORRHOEA, PELVIC PAIN, ABDOMINAL PAIN, HEAVY MENSTRUAL BLEEDING, ALOPECIA AND FATIGUE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR MIGRATION. TUBAL LIGATION ((B)(6) 2010). RIGHT TUBAL OSTIUM. TRAILING COILS IN UTERUS: 2. LEFT TUBAL OSTIUM. TRAILING COILS IN UTERUS: 2. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. BATCH NO C51076 PRODUCTION DATE 2014-04-25 EXPIRATION DATE 2017-04-30. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION: YES.'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: STILLBIRTH/MISCARRIAGE') AND ABORTION SPONTANEOUS ('PREGNANCY: STILLBIRTH/MISCARRIAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C51076) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING),"), PELVIC PAIN ("PELVIC/ABDOMINAL PAIN"), ABDOMINAL PAIN ("PELVIC/ABDOMINAL PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING"), ALOPECIA ("HAIR LOSS.") AND FATIGUE ("FATIGUE,") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, BACK PAIN, DYSMENORRHOEA, PELVIC PAIN, ABDOMINAL PAIN, HEAVY MENSTRUAL BLEEDING, ALOPECIA AND FATIGUE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR MIGRATION. TUBAL LIGATION (B)(6) 2010). RIGHT TUBAL OSTIUM. TRAILING COILS IN UTERUS: 2. LEFT TUBAL OSTIUM. TRAILING COILS IN UTERUS: 2. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2021: MR RECEIVED. REPORTER INFORMATION ,PATIENT DETAILS , LOT NO, OTHER RELEVANT HISTORY , LAB DATA ADDED AND RCC WAS UPDATED. 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 DEVICE DISLOCATION ('MIGRATION: YES.'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: STILLBIRTH/MISCARRIAGE') AND ABORTION SPONTANEOUS ('PREGNANCY: STILLBIRTH/MISCARRIAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING),"), PELVIC PAIN ("PELVIC/ABDOMINAL PAIN"), ABDOMINAL PAIN ("PELVIC/ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING"), ALOPECIA ("HAIR LOSS.") AND FATIGUE ("FATIGUE,") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, BACK PAIN, DYSMENORRHOEA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, ALOPECIA AND FATIGUE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR MIGRATION. TUBAL LIGATION ((B)(6) 2010). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED: EVENT INJURY WAS REPLACED BY DYSMENNORHEA (CRAMPING), BACK, PELVIC/ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PREGNANCY: STILLBIRTH/MISCARRIAGE, MIGRATION, FATIGUE, HAIR LOSS, DEVICE INEFFECTIVE ADDED. SUSPECT DRUG START DATE UPDATED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA WAS CONDUCTED; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891724 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 C51076 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other