BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10329203 · Received July 27, 2020

    Report

    Report Number
    2951250-2020-12295
    Event Type
    Injury
    Date Received
    July 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("EXTREME DEBILITATING MENSTRUAL PAIN"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, DYSMENORRHOEA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL AND PELVIC PAIN, HEAVY BLEEDING, AND DYSPAREUNIA, AMONG OTHER COMPLICATIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2011: RESULTS: CONFIRMED FULL OCCLUSION AND PROPER PLACEMENT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE IS DELETED FROM BAYER DATABASE AS THIS CASE WAS FOUND TO BE A DUPLICATE CASE OF EXISTING CASE (2017-110560) IN BAYER DATABASE. ALL THE INFORMATION THAT INCLUDES NEW EVENT DEPRESSION, REPORTER, REFERENCES AND SOURCE DOCUMENTS HAVE BEEN TRANSFERRED TO RETENTION CASE 2017-110560. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789130 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other