BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8877993 · Received August 9, 2019

    Report

    Report Number
    2951250-2019-04617
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    January 1, 2014
    Report Date
    August 14, 2019
    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 BACK PAIN ('PAIN-LOWER PORTION OF MY BACK') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840019-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "A COIL WAS NOT WANTING TO INSERT VERY EASILY". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED IRRITABILITY, MIGRAINE HEADACHE AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS SINCE 2014. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FLANK PAIN ("PAIN- SIDE ON MY RIGHT SIDE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE BACK PAIN AND FLANK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, VULVOVAGINAL MYCOTIC INFECTION, DYSMENORRHOEA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, FLANK PAIN, MENORRHAGIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: A THIRD ESSURE DEVICE IS PRESENT IN THE RIGHT HEMIPELVIS EXTRINSIC TO THE RIGHT FALLOPIAN TUBE. DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2016: 1. BENIGN INTRADERMAL MELANOCYTIC NEVUS, MUCOSA/SKIN OF LABIAL REGION, BIOPSY (A). 2. BENIGN UTERINE TUBE SEGMENTS, WITH ASSOCIATED ESSURE COILS, BILATERAL SALPINGECTOMIES (B).. PREGNANCY TEST URINE - ON (B)(6) 2016: UHCG NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING EVENT WAS CONFIRMED IN PATIENT'S MEDICAL RECORD- BACK PAIN. LOT NUMBER 840019 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: 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 BACK PAIN ('PAIN-LOWER PORTION OF MY BACK') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840019) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "A COIL WAS NOT WANTING TO INSERT VERY EASILY". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED IRRITABILITY, MIGRAINE HEADACHE AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS SINCE 2014. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FLANK PAIN ("PAIN- SIDE ON MY RIGHT SIDE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE BACK PAIN AND FLANK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, VULVOVAGINAL MYCOTIC INFECTION, DYSMENORRHOEA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, FLANK PAIN, MENORRHAGIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: A THIRD ESSURE DEVICE IS PRESENT IN THE RIGHT HEMIPELVIS EXTRINSIC TO THE RIGHT FALLOPIAN TUBE. DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2016: BENIGN INTRADERMAL MELANOCYTIC NEVUS, MUCOSA/SKIN OF LABIAL REGION, BIOPSY (A). BENIGN UTERINE TUBE SEGMENTS, WITH ASSOCIATED ESSURE COILS, BILATERAL SALPINGECTOMIES (B). PREGNANCY TEST URINE - ON (B)(6) 2016: UHCG NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING EVENT WAS CONFIRMED IN PATIENT'S MEDICAL RECORD- BACK PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-2019: PFS AND MR RECEIVED. ESSURE LOT NUMBER AND RACE ADDED. PRODUCT INDICATION AND ESSURE IMPLANT DATE UPDATED. PREVIOUSLY REPORTED ¿INJURY¿ WAS UPDATED TO LOWER PORTION OF MY BACK. FOLLOWING EVENTS WERE ADDED: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION, DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, PAIN-SIDE ON MY RIGHT SIDE AND DEVICE INSERTION DIFFICULT. REPORTERS, CONCOMITANT DRUG, MEDICAL HISTORY AND LAB DATA 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 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
    671367 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 840019-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS