BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9213002 · Received October 21, 2019

    Report

    Report Number
    2951250-2019-10573
    Event Type
    Injury
    Date Received
    October 21, 2019
    Report Date
    November 4, 2019
    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 ALLERGY TO METALS ('SHE HAD SEVERE NICKEL ALLERGY'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), SEIZURE ('SEIZURE') AND AUTONOMIC NEUROPATHY ('AUTONOMIC NEUROPATHY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTONOMIC NEUROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHE"), ACNE ("ACNE") AND DYSPEPSIA ("DIGESTIVE DISORDER"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) OF UTERUS AND FALLOPIAN TUBE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, GENITAL HAEMORRHAGE, SEIZURE, AUTONOMIC NEUROPATHY, HEADACHE, ACNE AND DYSPEPSIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, AUTONOMIC NEUROPATHY, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE AND SEIZURE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. NO 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('SHE HAD SEVERE NICKEL ALLERGY'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND SEIZURE ('SEIZURE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHE"), ACNE ("ACNE"), DYSPEPSIA ("DIGESTIVE DISORDER") AND AUTONOMIC NEUROPATHY ("AUTONOMIC NEUROPATHY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) OF UTERUS AND FALLOPIAN TUBE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, GENITAL HAEMORRHAGE, SEIZURE, HEADACHE, ACNE, DYSPEPSIA AND AUTONOMIC NEUROPATHY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, AUTONOMIC NEUROPATHY, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE AND SEIZURE TO BE RELATED TO ESSURE. NO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010318 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R