BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11291811 · Received February 8, 2021

    Report

    Report Number
    2951250-2021-00464
    Event Type
    Injury
    Date Received
    February 8, 2021
    Report Date
    February 9, 2021
    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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON 04-FEB-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-FEB-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12257016) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2004, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"), TENDONITIS ("TENDINITIS"), FATIGUE ("FATIGUE"), HYPOTONIA ("DECREASED TONE") AND DEPRESSED MOOD ("CHRONIC SADNESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MUSCULOSKELETAL PAIN, TENDONITIS, FATIGUE, HYPOTONIA AND DEPRESSED MOOD OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSED MOOD, FATIGUE, HYPOTONIA, MUSCULOSKELETAL PAIN, PELVIC PAIN AND TENDONITIS WITH ESSURE. LOT NUMBER: 12257016 MANUFACTURE DATE: 2004-03 EXPIRATION DATE: 2006-02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-FEB-2021: QUALITY-SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: (B)(4)) ON 04-FEB-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12257016) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2004, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINT PAIN"), TENDONITIS ("TENDINITIS"), FATIGUE ("FATIGUE"), HYPOTONIA ("DECREASED TONE") AND DEPRESSED MOOD ("CHRONIC SADNESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MYALGIA, ARTHRALGIA, TENDONITIS, FATIGUE, HYPOTONIA AND DEPRESSED MOOD OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, DEPRESSED MOOD, FATIGUE, HYPOTONIA, MYALGIA, PELVIC PAIN AND TENDONITIS WITH ESSURE. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF 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
    193370 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS202 12257016 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R