BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9109140 · Received September 24, 2019

    Report

    Report Number
    2951250-2019-08148
    Event Type
    Injury
    Date Received
    September 24, 2019
    Report Date
    March 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND MENORRHAGIA ('BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD LOSS ANAEMIA ("ANEMIA"), PELVIC PAIN ("PELVIC PAIN/SEVERE PAIN IN PELVIC REGION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), BACK PAIN ("BACK PAIN") AND DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, BLOOD LOSS ANAEMIA, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN AND DEVICE EXPULSION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLOOD LOSS ANAEMIA, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA, BACK PAIN, MENORRHAGIA, ANEMIA, MIGRATION. PREVIOUSLY REPORTED INSERTION DATE: (B)(6) 2012 MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. NEW EVENTS PARTIAL EXPULSION OF DEVICE AND ABNORMAL BLEEDING (GENERAL) WERE ADDED. LOT NUMBER WAS ADDED WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND MENORRHAGIA ('BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD LOSS ANAEMIA ("ANEMIA"), PELVIC PAIN ("PELVIC PAIN/SEVERE PAIN IN PELVIC REGION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), BACK PAIN ("BACK PAIN") AND DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, BLOOD LOSS ANAEMIA, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN AND DEVICE EXPULSION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLOOD LOSS ANAEMIA, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA, BACK PAIN, MENORRHAGIA, ANEMIA, MIGRATION. PREVIOUSLY REPORTED INSERTION DATE: (B)(6) 2012. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ('MIGRATION'), MENORRHAGIA ('BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND BLOOD LOSS ANAEMIA ('ANEMIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD LOSS ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/SEVERE PAIN IN PELVIC REGION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, BLOOD LOSS ANAEMIA, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLOOD LOSS ANAEMIA, DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA, BACK PAIN, MENORRHAGIA, ANEMIA, MIGRATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY NOS" REPLACED WITH "PELVIC PAIN", EVENTS-" ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, MENORRHAGIA, ANEMIA, MIGRATION" REPORTER¿S INFORMATION, PATIENT¿S DEMOGRAPHICS WERE ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE HAVE CONDUCTED A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; 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
    905114 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882184 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R