BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10148784 · Received June 12, 2020

    Report

    Report Number
    2951250-2020-08698
    Event Type
    Injury
    Date Received
    June 12, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE HAEMORRHAGE ('HEMATOMETRA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 731808-INV, 822365) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PELVIC PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, TOTAL, LAPAROSCOPIC, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 2 COILS WERE EASILY COUNTED AND VISUALIZED; VISUALIZATION WAS SOMEWHAT LIMITED BY THE FLUFFY ENDOMETRIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST: ON (B)(6) 2019: UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX- CHRONIC CERVICITIS. ENDOMETRIUM- BENIGN EARLY SECRETORY PATTERN. MYOMETRIUM- ADENOMYOSIS. FALLOPIAN TUBES - NO PATHOLOGIC ABNORMALITY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUL-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT).FU 2 AND 3 PROCESSED TOGETHER. ON 3-MAR-2020: PFS RECEIVED. REPORTER'S INFORMATION ADDED. FU 2 AND 3 PROCESSED TOGETHER. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF UTERINE HEMORRHAGE ('HEMATOMETRA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365, 731808) INSERTED FOR FEMALE STERILIZATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PELVIC PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, TOTAL, LAPAROSCOPIC, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: 2 COILS WERE EASILY COUNTED AND VISUALIZED; VISUALIZATION WAS SOMEWHAT LIMITED BY THE FLUFFY ENDOMETRIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2019: UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX- CHRONIC CERVICITIS. ENDOMETRIUM- BENIGN EARLY SECRETORY PATTERN. MYOMETRIUM- ADENOMYOSIS. FALLOPIAN TUBES - NO PATHOLOGIC ABNORMALITY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUL-2020: QUALITY SAFETY EVALUATION OF PTC . 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF UTERINE HAEMORRHAGE ('HEMATOMETRA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365, 731808) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PELVIC PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, TOTAL, LAPAROSCOPIC, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 2 COILS WERE EASILY COUNTED AND VISUALIZED; VISUALIZATION WAS SOMEWHAT LIMITED BY THE FLUFFY ENDOMETRIUM DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2019: UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX- CHRONIC CERVICITIS. ENDOMETRIUM- BENIGN EARLY SECRETORY PATTERN. MYOMETRIUM- ADENOMYOSIS. FALLOPIAN TUBES - NO PATHOLOGIC ABNORMALITY. 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
    614417 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 731808-INV, 822365 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R