BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9840850 · Received March 17, 2020

    Report

    Report Number
    2951250-2020-02470
    Event Type
    Injury
    Date Received
    March 17, 2020
    Report Date
    April 1, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/CHRONIC ") AND METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS),"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND METRORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2011, (B)(6) 2012 . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/CHRONIC ") AND METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS),"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND METRORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE:- (B)(6) 2011, (B)(6) 2012 AND (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PLAINTIFF FACT SHEET RECEIVED. CASE BECAME INCIDENT. LOT NUMBER ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL). EVENT MENORRHAGIA WAS MADE SERIOUS INCIDENT. REPORTER INFORMATION, AKA NAME, LAB DATA WERE ADDED. EVENT GENITAL HEMORRHAGE WAS UPDATED TO NONSERIOUS. 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
    303833 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940969 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R