BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9165840 · Received October 8, 2019

    Report

    Report Number
    2951250-2019-09874
    Event Type
    Injury
    Date Received
    October 8, 2019
    Report Date
    October 18, 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 PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2013 , THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASTHENIA ("ASTHENIA"), NECK PAIN ("NECK PAIN"), ABDOMINAL PAIN ("ABDOMINO PAIN"), DYSMENORRHOEA ("DYSMENORRHEA") AND ABDOMINAL DISTENSION ("BLOATED AT NIGHT"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE INSIDE THE TUBES). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASTHENIA, NECK PAIN, ABDOMINAL PAIN, DYSMENORRHOEA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ABDOMINAL PAIN, ASTHENIA, DYSMENORRHOEA, NECK PAIN AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: THE POSTOPERATIVE COURSE (ESSURE REMOVAL) WAS SIMPLE. ABSENCE OF TUMOR PROLIFERATION UPON PATHOLOGICAL EXAMINATION. THE DEVICE IS NOT AVAILABLE FOR EXPERTISE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: HEALTH AUTHORITY CONFIRMED THAT THIS RECORD (ANSM #R1918771) WAS A DUPLICATE TO RECORD FR-BAYER-2019-181235 (ANSM # R1918062) TO WHICH ALL INFORMATION WILL BE TRANSFERRED. THEN THIS DUPLICATE RECORD FR-BAYER-2019-181869 WILL BE DELETED 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 04-OCT-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASTHENIA ("ASTHENIA"), NECK PAIN ("NECK PAIN"), ABDOMINAL PAIN ("ABDOMINO PAIN"), DYSMENORRHOEA ("DYSMENORRHEA") AND ABDOMINAL DISTENSION ("BLOATED AT NIGHT"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE INSIDE THE TUBES). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASTHENIA, NECK PAIN, ABDOMINAL PAIN, DYSMENORRHOEA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ABDOMINAL PAIN, ASTHENIA, DYSMENORRHOEA, NECK PAIN AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: THE POSTOPERATIVE COURSE (ESSURE REMOVAL) WAS SIMPLE. ABSENCE OF TUMOR PROLIFERATION UPON PATHOLOGICAL EXAMINATION. THE DEVICE IS NOT AVAILABLE FOR EXPERTISE. 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
    959530 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R