BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9162300 · Received October 7, 2019

    Report

    Report Number
    2951250-2019-09736
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    February 28, 2017
    Report Date
    October 29, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 58565 NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT PERFORMED ESSURE CONFIRMATION TEST." THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE BLEEDING, ENDOCERVICITIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND TRAMADOL FROM (B)(6) 2016 TO (B)(6) 2017. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PELVIC PAIN ("PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD NOT RESOLVED AND THE ABDOMINAL PAIN AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2015, SHE IMPLANTED ESSURE (DISCREPANCY NOTED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT) AND PFS RECEIVED: UPDATE OF INFORMATION (BATCH IS NOTVALID) EVENT PELVIC AND ABDOMINAL PAIN ADDED. ON 15-OCT-2019: FU3 AND FU4 PROCESSED TOGETHER. NO VALID 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 58565) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT PERFORMED ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE BLEEDING, ENDOCERVICITIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND TRAMADOL FROM (B)(6) 2016 TO (B)(6) 2017. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2015, SHE IMPLANTED ESSURE (DISCREPANCY NOTED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-SEP-2019: REPORTER¿S DETAILS UPDATED AND PATIENT DEMOGRAPHICS, MEDICAL HISTORY WERE ADDED. ESSURE INDICATION UPDATED. ADDED LOT NUMBER. ON (B)(6) 2017, SHE EXPLANTED ESSURE. INJURY EVENT WAS UPDATED TO ABNORMAL BLEEDING (GENERAL), DYSMENORRHEA (CRAMPING), ABNORMAL BLEEDING (VAGINAL/ MENORRHAGIA), LOWER ABDOMINAL PAIN, PATIENT DID NOT PERFORMED ESSURE CONFIRMATION TEST. 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
    956142 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 58565 NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R NARCO| NARCO| TRAMADOL| TRAMADOL