BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12556155 · Received September 30, 2021

    Report

    Report Number
    2951250-2021-03254
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    January 1, 2012
    Report Date
    October 11, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED SHOULDER OPERATION IN 2009, EPIGASTRIC PAIN, NAUSEA, VOMITING, DIARRHEA, HYPERTENSION, SEIZURES AND ANEMIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2008 TO OCTOBER 2011; FOR AN UNREPORTED INDICATION: ZOFRAN IN 2012. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PREGNANCY WITH MIRENA. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, IRREGULAR PERIODS, CANDIDA ALBICANS INFECTION, THROMBOCYTOPENIA, CERVIX INFLAMMATION, ADENOMYOSIS AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED LISINOPRIL SINCE 2012. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA / HEAVY CRAMPING") AND URINARY TRACT INFECTION ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)-TYPE: UTI"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING MENORRHAGIA/MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, FATIGUE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT DID NOT HAVE HER ESSURE REMOVED, HOWEVER, IS CURRENTLY PLANNING FOR REMOVAL. LOT NUMBER:841528 MANUFACTURING DATE: 2011-03 EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-OCT-2021: 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED SHOULDER OPERATION IN 2009, EPIGASTRIC PAIN, NAUSEA, VOMITING, DIARRHEA, HYPERTENSION, SEIZURES AND ANEMIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2008 TO (B)(6) 2011; FOR AN UNREPORTED INDICATION: ZOFRAN IN 2012. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PREGNANCY WITH MIRENA. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, IRREGULAR PERIODS, CANDIDA ALBICANS INFECTION, THROMBOCYTOPENIA, CERVIX INFLAMMATION, ADENOMYOSIS AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED LISINOPRIL SINCE 2012. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA / HEAVY CRAMPING") AND URINARY TRACT INFECTION ("INFECTION(BLADDER/ URINARY TRACT/ VAGINAL)- TYPE: UTI"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING MENORRHAGIA/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, FATIGUE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT DID NOT HAVE HER ESSURE REMOVED, HOWEVER, IS CURRENTLY PLANNING FOR REMOVAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: ABDOMINAL PAIN AND URINARY TRACT INFECTION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2021: MEDICAL RECORD RECEIVED. CASE BECAME SERIOUS INCIDENT AS REMOVAL WAS DONE. REPORTER, MEDICAL HISTORY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451898 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 841528 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R LISINOPRIL.| LISINOPRIL.| LISINOPRIL