BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 11322181 · Received February 12, 2021

    Report

    Report Number
    2951250-2021-00500
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Report Date
    February 17, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICES PROBABLY BROKE INSIDE PATIENT´S BODY'), DEVICE DISLOCATION ('ESSURE WAS NOT IN THE CORRECT POSITION IN THE PATIENT´S FALLOPIAN TUBE / THE DEVICE WAS ON VERGE OF PERFORATING THE INTERNAL ORGANS') AND UTERINE INFLAMMATION ('UTERINE INFLAMMATION') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("ABDOMINAL PAIN LOWER AFTER INSERTION"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("INTENSE CRAMP IN LOWER ABDOMEN/TWINGES"), BREAST PAIN ("BREAST PAIN"), ABDOMINAL DISTENSION ("DISTENSION"), MENORRHAGIA ("INCREASED MENSTRUAL FLOW, DURING UNTIL 15 DAYS, WITH CLOTS"), DYSPAREUNIA ("PAIN DURING AND AFTER INTERCOURSE"), VAGINAL DISCHARGE ("STRONG SMELL DUE TO VAGINAL FLUID"), VULVOVAGINAL PRURITUS ("FREQUENTLY INCREASED VAGINAL DISCHARGE WITH ITCHING"), DYSMENORRHOEA ("INTENSE PAIN DURING MENSTRUAL FLOW") AND DIARRHOEA ("SPORADIC INTERMITTENT DIARRHEA ASSOCIATED WITH THE MENSTRUAL CYCLE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OEDEMA ("OEDEMA"), HEADACHE ("INTENSE HEADACHES"), PAIN IN EXTREMITY ("PAIN IN LEGS"), PERIPHERAL SWELLING ("SWOLLEN LEGS"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LUMBAR PAIN"), PELVIC PAIN ("PELVIC PAIN/TWINGES/UTERINE PERFORATION SENSATION"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER INTERCOURSE"), ARTHRALGIA ("JOINT PAIN"), MOOD ALTERED ("CONSTANT MOOD CHANGES"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("ADENOMYOSIS SUSPECTED"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN ABDOMEN"), PAIN ("GENERALIZED PAIN"), ANXIETY DISORDER ("ANXIETY DISORDER"), NERVOUSNESS ("NERVOUSNESS"), STRESS ("STRESS") AND POLYMENORRHAGIA ("HYPERPOLYMENORRHEA (INCREASED FLOW AND FREQUENCY OF MENSTRUATION)"). THE PATIENT WAS TREATED WITH DICLOFENAC SODIUM (ANTI-INFLAMMATORY) AND PARACETAMOL (PAIN RELIEF). AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, UTERINE INFLAMMATION, ABDOMINAL PAIN LOWER, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, PELVIC PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, ARTHRALGIA, MOOD ALTERED, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, VAGINAL DISCHARGE, VULVOVAGINAL PRURITUS, ANXIETY DISORDER, NERVOUSNESS, STRESS, DYSMENORRHOEA, DIARRHOEA, PROCEDURAL PAIN AND POLYMENORRHAGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD ALTERED, NERVOUSNESS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHAGIA, PROCEDURAL PAIN, STRESS, TREMOR, UTERINE INFLAMMATION, VAGINAL DISCHARGE AND VULVOVAGINAL PRURITUS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON AN UNKNOWN DATE: PELVIS X-RAY SHOWS LINEAR METALLIC MATERIAL IN PELVIS IN UTERUS TOPOGRAPHY. 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 15-FEB-2021: QUALITY SAFETY EVALUATION OF PTC 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 DEVICE BREAKAGE ('DEVICES PROBABLY BROKE INSIDE PATIENT´S BODY'), DEVICE DISLOCATION ('ESSURE WAS NOT IN THE CORRECT POSITION IN THE PATIENT´S FALLOPIAN TUBE / THE DEVICE WAS ON VERGE OF PERFORATING THE INTERNAL ORGANS') AND UTERINE INFLAMMATION ('UTERINE INFLAMMATION') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("ABDOMINAL PAIN LOWER AFTER INSERTION"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("INTENSE CRAMP IN LOWER ABDOMEN/TWINGES"), BREAST PAIN ("BREAST PAIN"), ABDOMINAL DISTENSION ("DISTENSION"), MENORRHAGIA ("INCREASED MENSTRUAL FLOW, DURING UNTIL 15 DAYS, WITH CLOTS"), DYSPAREUNIA ("PAIN DURING AND AFTER INTERCOURSE"), VAGINAL DISCHARGE ("STRONG SMELL DUE TO VAGINAL FLUID"), VULVOVAGINAL PRURITUS ("FREQUENTLY INCREASED VAGINAL DISCHARGE WITH ITCHING"), DYSMENORRHOEA ("INTENSE PAIN DURING MENSTRUAL FLOW") AND DIARRHOEA ("SPORADIC INTERMITTENT DIARRHEA ASSOCIATED WITH THE MENSTRUAL CYCLE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OEDEMA ("OEDEMA"), HEADACHE ("INTENSE HEADACHES"), PAIN IN EXTREMITY ("PAIN IN LEGS"), PERIPHERAL SWELLING ("SWOLLEN LEGS"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LUMBAR PAIN"), PELVIC PAIN ("PELVIC PAIN/TWINGES/UTERINE PERFORATION SENSATION"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER INTERCOURSE"), ARTHRALGIA ("JOINT PAIN"), MOOD ALTERED ("CONSTANT MOOD CHANGES"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("ADENOMYOSIS SUSPECTED"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN ABDOMEN"), PAIN ("GENERALIZED PAIN"), ANXIETY DISORDER ("ANXIETY DISORDER"), NERVOUSNESS ("NERVOUSNESS"), STRESS ("STRESS") AND POLYMENORRHAGIA ("HYPERPOLYMENORRHEA (INCREASED FLOW AND FREQUENCY OF MENSTRUATION)"). THE PATIENT WAS TREATED WITH DICLOFENAC SODIUM (ANTI-INFLAMMATORY) AND PARACETAMOL (PAIN RELIEF). AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, UTERINE INFLAMMATION, ABDOMINAL PAIN LOWER, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, PELVIC PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, ARTHRALGIA, MOOD ALTERED, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, VAGINAL DISCHARGE, VULVOVAGINAL PRURITUS, ANXIETY DISORDER, NERVOUSNESS, STRESS, DYSMENORRHOEA, DIARRHOEA, PROCEDURAL PAIN AND POLYMENORRHAGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD ALTERED, NERVOUSNESS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHAGIA, PROCEDURAL PAIN, STRESS, TREMOR, UTERINE INFLAMMATION, VAGINAL DISCHARGE AND VULVOVAGINAL PRURITUS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON AN UNKNOWN DATE: PELVIS X-RAY SHOWS LINEAR METALLIC MATERIAL IN PELVIS IN UTERUS TOPOGRAPHY. 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
    219481 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 925777 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other