BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8633629 · Received May 22, 2019

    Report

    Report Number
    2951250-2019-02084
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    January 1, 2013
    Report Date
    May 29, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAINS') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901338) INSERTED. 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), CYSTITIS ("CYSTITIS"), FATIGUE ("CHRONIC FATIGUE"), ANGIOEDEMA ("GIANT URTICARIA"), MALAISE ("MALAISE") AND CERVICOBRACHIAL SYNDROME ("CERVICOBRACHIAL NEURALGIA OF TENSION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS, FATIGUE, ANGIOEDEMA, MALAISE AND CERVICOBRACHIAL SYNDROME OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANGIOEDEMA, CERVICOBRACHIAL SYNDROME, CYSTITIS, FATIGUE, MALAISE AND PELVIC PAIN WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAINS') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901338) INSERTED. 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), CYSTITIS ("CYSTITIS"), FATIGUE ("CHRONIC FATIGUE"), ANGIOEDEMA ("GIANT URTICARIA"), MALAISE ("MALAISE") AND NEURALGIA ("CERVICOBRACHIAL NEURALGIA OF TENSION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS, FATIGUE, ANGIOEDEMA, MALAISE AND NEURALGIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANGIOEDEMA, CYSTITIS, FATIGUE, MALAISE, NEURALGIA AND PELVIC PAIN WITH ESSURE. 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 NON-CONFORMANCE DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424510 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 901338 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R