BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8788467 · Received July 15, 2019

    Report

    Report Number
    2951250-2019-03823
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    March 26, 2018
    Report Date
    October 30, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S FAMILY HISTORY INCLUDED UTERINE BLEEDING AND UTERINE CANCER. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID FROM JUNE 2018 TO JANUARY 2019, BIOTIN FROM JUNE 2018 TO JANUARY 2019, FOLIC ACID FROM JUNE 2018 TO JANUARY 2019, MAGNESIUM FROM NOVEMBER 2018 TO JANUARY 2019, TOCOPHEROL FROM JUNE 2018 TO JANUARY 2019 AND VITAMIN D NOS (VITAMIN D) FROM JUNE 2018 TO JANUARY 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ ABDOMINAL CRAMPS - MENSTRUAL CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 6 YEARS 2 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND ABLATION WAS DONE IN 2012). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS (B)(6) 2012 INITIALLY. IN CURRENT PFS JUL2012 WAS GIVEN LOT NUMBER: 952109 MANUFACTURE DATE: 2012-02 EXPIRATION DATE: 2015-02 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) 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 "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S FAMILY HISTORY INCLUDED UTERINE BLEEDING AND UTERINE CANCER. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID FROM (B)(6) 2018 TO (B)(6) 2019, BIOTIN FROM (B)(6) 2018 TO (B)(6) 2019, FOLIC ACID FROM (B)(6) 2018 TO (B)(6) 2019, MAGNESIUM FROM (B)(6) 2018 TO (B)(6) 2019, TOCOPHEROL FROM (B)(6) 2018 TO (B)(6) 2019 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2018 TO (B)(6) 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ ABDOMINAL CRAMPS - MENSTRUAL CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 6 YEARS 2 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND ABLATION WAS DONE IN 2012). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS (B)(6) 2012 INITIALLY. IN CURRENT PFS JUL2012 WAS GIVEN LOT NUMBER: 952109 MANUFACTURE DATE: 2012-02 EXPIRATION DATE: 2015-02 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2019: PFS RECEIVED- NEW EVENT SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST WAS ADDED. REPORTER INFORMATION WAS 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S FAMILY HISTORY INCLUDED UTERINE BLEEDING AND UTERINE CANCER. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID FROM (B)(6) 2018 TO (B)(6) 2019, BIOTIN FROM (B)(6) 2018 TO (B)(6) 2019, FOLIC ACID FROM (B)(6) 2018 TO (B)(6) 2019, MAGNESIUM FROM (B)(6) 2018 TO (B)(6) 2019, TOCOPHEROL FROM (B)(6) 2018 TO (B)(6) 2019 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2018 TO (B)(6) 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ ABDOMINAL CRAMPS - MENSTRUAL CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 6 YEARS 2 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND ABLATION WAS DONE IN 2012). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, VAGINAL DISCHARGE AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS (B)(6) 2012 INITIALLY. IN CURRENT PFS (B)(6) 2012 WAS GIVEN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-JUL-2019: PFS RECEIVED: CASE BECAME VALID AND INCIDENT. PREVIOUSLY REPORTED INJURY NOS WAS REPLACED WITH NEW EVENTS GENITAL BLEEDING, MENORRHAGIA, VAGINAL BLEEDING, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE, UTERINE FIBROID, PELVIC PAIN. LOT NUMBER, REPORTER INFORMATION, PATIENTS DOB, DEMOGRAPHICS, DATE OF REMOVAL, EVENTS ONSET DATE AND CONCOMITANT DRUGS WERE ADDED. ON 9-JUL-2019: FU 2 AND FU 3 PROCESSED TOGETHER. MEDICAL RECORD RECEIVED. REPORTER AND FAMILY HISTORY 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582446 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952109 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R ASCORBIC ACID| ASCORBIC ACID| ASCORBIC ACID| BIOTIN| BIOTIN| BIOTIN| FOLIC ACID| FOLIC ACID| FOLIC ACID| MAGNESIUM| MAGNESIUM| MAGNESIUM| TOCOPHEROL| TOCOPHEROL| TOCOPHEROL| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| ASCORBIC ACID| BIOTIN| FOLIC ACID| MAGNESIUM| TOCOPHEROL| VITAMIN D [VITAMIN D NOS]