BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9942538 · Received April 9, 2020

    Report

    Report Number
    2951250-2020-03143
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    June 1, 2012
    Report Date
    May 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/ PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904752) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS INCONTINENCE, PULMONARY EMBOLISM, MICTURITION URGENCY AND POSTPARTUM STATE. CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), DYSMENORRHOEA ("DYSMENNORHEA") AND URINARY TRACT INFECTION ("UTI (URINARY TRACT INFECTION)"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA HAD RESOLVED AND THE ABDOMINAL PAIN, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, ANXIETY AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE IMPLANT DATE WAS (B)(6) 2012 (AS REPORTED, DISCREPANCY NOTED). DISCREPANCY NOTED IN ESSURE EXPLANT DATE- (B)(6) 2010. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, BILATERAL OCCLUSION. ULTRASOUND PELVIS - ON (B)(6) 2019: IMPRESSION: AT LEAST TWO UTERINE FIBROIDS, INCLUDING A LARGE FIBROID MEASURING UP TO 9 CM IN DIAMETER. PELVIC MRI MAY BE BENEFICIAL DEPENDING ON THE CLINICAL DETAILS. 2. ENDOMETRIUM DOES NOT APPEAR THICKENED. TRACE FLUID WITHIN THE ENDOMETRIAL CANAL IS NONSPECIFIC BUT MAY REPRESENT BLOOD PRODUCTS OR MUCOUS. 3. THE RIGHT OVARY APPEARS NORMAL. THE LEFT OVARY WAS NOT DIAGNOSTICALLY VISUALIZED. LOT NUMBER: 904752 MANUFACTURE DATE: 2011-10 EXPIRATION DATE: 2014-10. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PLAINTIFF FACT SHEET RECEIVED. EVENT¿ UTI (URINARY TRACT INFECTION) AND DYSMENORRHEA¿ WAS ADDED. THE OUTCOME OF EVENTS" PELVIC PAIN, GENITAL BLEEDING AND MENORRHAGIA WAS UPDATED TO RECOVERED/RESOLVED. 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 ('PHYSICAL PAIN/ PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904752) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS INCONTINENCE, PULMONARY EMBOLISM, MICTURITION URGENCY AND POSTPARTUM STATE. CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BLADDER DISORDER ("BLADDER PROBLEM") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE IMPLANT DATE WAS (B)(6) 2012 (AS REPORTED, DISCREPANCY NOTED). DISCREPANCY NOTED IN ESSURE EXPLANT DATE (B)(6) 2010. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, BILATERAL OCCLUSION.. ULTRASOUND PELVIS ON (B)(6) 2019: IMPRESSION: AT LEAST TWO UTERINE FIBROIDS, INCLUDING A LARGE FIBROID MEASURING UP TO 9 CM IN DIAMETER. PELVIC MRI MAY BE BENEFICIAL DEPENDING ON THE CLINICAL DETAILS. ENDOMETRIUM DOES NOT APPEAR THICKENED. TRACE FLUID WITHIN THE ENDOMETRIAL CANAL IS NONSPECIFIC BUT MAY REPRESENT BLOOD PRODUCTS OR MUCOUS. THE RIGHT OVARY APPEARS NORMAL. THE LEFT OVARY WAS NOT DIAGNOSTICALLY VISUALIZED.. LOT NUMBER: 904752 MANUFACTURE DATE: 2011-10 EXPIRATION DATE: 2014-10 CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: PFS RECEIVED- CASE WAS UPGRADED FROM NON-SERIOUS INCIDENT TO SERIOUS INCIDENT. 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 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
    410459 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 904752 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R