BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8370794 · Received February 26, 2019

    Report

    Report Number
    2951250-2019-00814
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 1, 2014
    Report Date
    May 27, 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM- HEATH AUTHORITIES IN (B)(6), REFERENCE NUMBER: (B)(4)) ON 25-FEB-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 24-MAY-2019. 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. 5070466-INVALID) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENERAL PHYSICAL HEALTH DETERIORATION ("GENERAL STATE ALTERATION"), MYALGIA ("MUSCULAR PAIN"), ARTHRALGIA ("JOINT PAIN"), TENDON PAIN ("TENDON PAIN"), MENORRHAGIA ("HEMORRHAGIC PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), SWELLING ("SWELLING"), DYSPEPSIA ("DIGESTIVE DISORDERS"), DRY EYE ("OCULAR DRYNESS"), PRURITUS ("ITCHING"), FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, MYALGIA, ARTHRALGIA, TENDON PAIN, MENORRHAGIA, ABDOMINAL DISTENSION, SWELLING, DYSPEPSIA, DRY EYE, PRURITUS, FATIGUE, WEIGHT INCREASED AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ARTHRALGIA, DRY EYE, DYSPEPSIA, FATIGUE, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, MENORRHAGIA, MYALGIA, PELVIC PAIN, PRURITUS, SWELLING, TENDON PAIN AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: THE REMOVAL OF IMPLANTS WAS CONSIDERED. LOT 5070466 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-MAY-2019: QUALITY SAFETY EVALUATION OF PTC NO VALID LOT NUMBER 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) - HEATH AUTHORITIES IN (B)(6), REFERENCE NUMBER: (B)(4)) ON 25-FEB-2019. 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. 5070466) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEELING ABNORMAL ("GENERAL STATE ALTERATION"), MYALGIA ("MUSCULAR PAIN"), ARTHRALGIA ("JOINT PAIN"), TENDON PAIN ("TENDON PAIN"), MENORRHAGIA ("HEMORRHAGIC PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), SWELLING ("SWELLING"), DYSPEPSIA ("DIGESTIVE DISORDERS"), DRY EYE ("OCULAR DRYNESS"), PRURITUS ("ITCHING"), FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). AT THE TIME OF THE REPORT, THE PELVIC PAIN, FEELING ABNORMAL, MYALGIA, ARTHRALGIA, TENDON PAIN, MENORRHAGIA, ABDOMINAL DISTENSION, SWELLING, DYSPEPSIA, DRY EYE, PRURITUS, FATIGUE, WEIGHT INCREASED AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ARTHRALGIA, DRY EYE, DYSPEPSIA, FATIGUE, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MYALGIA, PELVIC PAIN, PRURITUS, SWELLING, TENDON PAIN AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: THE REMOVAL OF IMPLANTS WAS CONSIDERED. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162849 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 5070466-INVALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other