BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9165013 · Received October 8, 2019

    Report

    Report Number
    2951250-2019-09814
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 26, 2018
    Report Date
    January 29, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION UTERUS') AND DEVICE DISLOCATION ('MIGRATION') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO THIS TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MORBID OBESITY, BREAST CANCER, URINARY INCONTINENCE, ANEMIA AND PICA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6) 2018 FOR ANXIETY AS WELL AS AMLODIPINE BESILATE (NORVASC), DOCUSATE SODIUM (COLACE) SINCE 2017, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) IN (B)(6) 2018 AND ONDANSETRON (ZOFRAN) SINCE 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/PROLONGED MENSES") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("RASHES OR SKIN CONDITIONS TYPE: UNSPECIFIED"). ON (B)(6) 2018, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN") AND VAGINAL DISCHARGE ("VAG. DISCHARGE"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, VAGINAL DISCHARGE, GENITAL HAEMORRHAGE AND DERMATITIS ALLERGIC OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DERMATITIS ALLERGIC, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: PREVIOUSLY ESSURE INSERTION DATE WAS GIVEN AS (B)(6) 2008. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.9 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PLAINTIFF FACT SHEET RECEIVED. EVENTS¿ PERFORATION (UTERUS), ABNORMAL BLEEDING (GENERAL), AND RASHES OR SKIN CONDITIONS TYPE: UNSPECIFIED) WERE ADDED. THIS CASE IS MEDICALLY CONFIRMED. PATIENT DEMOGRAPHICS, MEDICAL HISTORY, ESSURE LOT NUMBER, CONCOMITANT MEDICATIONS AND REPORTER INFORMATION WERE ADDED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO THIS TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL DISCHARGE ("VAG. DISCHARGE"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: PREVIOUSLY ESSURE INSERTION DATE WAS GIVEN AS (B)(6) 2008. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: PFS RECEIVED-CASE BECOMES INCIDENT. EVENT INJURY WAS REMOVED. NEW EVENTS PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), MIGRATION, VAGINAL DISCHARGE AND PLAINTIFF DID NOT UNDERGO THIS TEST WERE ADDED. IMPLANT DATE WAS UPDATED. PRODUCT INDICATION WAS ADDED. PATIENT¿S DATE OF BIRTH WAS ADDED. REPORTER¿S INFORMATION WAS ADDED. NO LOT NUMBER OR DEVICE SAMPLE 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
    961760 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822372 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other COLACE| NORCO| NORVASC| XANAX| ZOFRAN [ONDANSETRON]