BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9336863 · Received November 18, 2019

    Report

    Report Number
    2951250-2019-11535
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    January 1, 2013
    Report Date
    November 22, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN INTENSIFIED DURING OVULATION') IN A 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. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN INTENSIFIED DURING OVULATION"), SLEEP DISORDER ("SLEEP HYGIENE DISORDERS") AND NIGHT SWEATS ("OVERNIGHT SWEATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO CHEMICALS ("METHYLDIBROMOGLUTARONITRILE AND SILVER NITRATE SENSITIVITY"), NAUSEA ("NAUSEA") AND ALLERGY TO METALS ("RHODIUM SENSITIVITY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, SLEEP DISORDER, NIGHT SWEATS, ALLERGY TO CHEMICALS, NAUSEA AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO CHEMICALS, ALLERGY TO METALS, MENORRHAGIA, NAUSEA, NIGHT SWEATS, PELVIC PAIN AND SLEEP DISORDER TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2019: POSITIVE RESULTS FOR METHYLDIBROMOGLUTARONITRILE, RHODIUM AND SILVER NITRATE SENSITIVITY. ULTRASOUND SCAN - ON (B)(6) 2012: CONFIRMED ESSURE POSITION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-NOV-2019: QUALITY SAFETY EVALUATION OF PTC. THIS CASE WILL BE DELETED FROM BAYER PV DATABASE BECAUSE THIS IS A DUPLICATE FROM 2018-112813 CASE. 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 WILL CONDUCT 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN INTENSIFIED DURING OVULATION') IN A 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. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN INTENSIFIED DURING OVULATION"), SLEEP DISORDER ("SLEEP HYGIENE DISORDERS") AND NIGHT SWEATS ("OVERNIGHT SWEATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO CHEMICALS ("METHYLDIBROMOGULATRONITRILE AND SILVER NITRATE SENSITIVITY"), NAUSEA ("NAUSEA") AND ALLERGY TO METALS ("RHODIUM SENSITIVITY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, SLEEP DISORDER, NIGHT SWEATS, ALLERGY TO CHEMICALS, NAUSEA AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO CHEMICALS, ALLERGY TO METALS, MENORRHAGIA, NAUSEA, NIGHT SWEATS, PELVIC PAIN AND SLEEP DISORDER TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2019: POSITIVE RESULTS FOR METHYL DIBROMOGULATRONITRILE, RHODIUM AND SILVER NITRATE SENSITIVITY. ULTRASOUND SCAN: ON (B)(6) 2012: CONFIRMED ESSURE POSITION. 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 WILL CONDUCT 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
    1132072 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R