BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10384424 · Received August 10, 2020

    Report

    Report Number
    2951250-2020-12953
    Event Type
    Injury
    Date Received
    August 10, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823482-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES, PARTIAL RIGHT OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: TWO COILS WERE VISUALIZED PROTRUDING FROM EACH OSTIA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: OTHER THAN WHAT MAY BE A MINIMAL TRACE OF CONTRAST IN THE RIGHT FALLOPIAN TUBE ADJACENT TO THE MIDPORTION OF THE ESSURE THERE IS NO EVIDENCE OF TUBAL PATENCY. UTERINE CAVITY NORMAL IN APPEARANCE. LOT # REPORTED (823482) IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINTS). 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823482) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES, PARTIAL RIGHT OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: TWO COILS WERE VISUALIZED PROTRUDING FROM EACH OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: OTHER THAN WHAT MAY BE A MINIMAL TRACE OF CONTRAST IN THE RIGHT FALLOPIAN TUBE ADJACENT TO THE MIDPORTION OF THE ESSURE THERE IS NO EVIDENCE OF TUBAL PATENCY. UTERINE CAVITY NORMAL IN APPEARANCE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851131 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 823482-INVALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R