BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7110135 · Received December 12, 2017

    Report

    Report Number
    2951250-2017-10650
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    September 24, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEADACHE ("HEADACHE"), FEELING ABNORMAL ("BRAIN FOG"), MIGRAINE ("MIGRAINE"), ALOPECIA ("HAIR THINNING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE,"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) ") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTEROCTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, HEADACHE, FEELING ABNORMAL, MIGRAINE, ALOPECIA, MENORRHAGIA, CYSTITIS AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CYSTITIS, DYSMENORRHOEA, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-AUG-2018: UPDATE OF QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEADACHE ("HEADACHE"), FEELING ABNORMAL ("BRAIN FOG"), MIGRAINE ("MIGRAINE"), ALOPECIA ("HAIR THINNING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE,"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) ") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTEROCTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, HEADACHE, FEELING ABNORMAL, MIGRAINE, ALOPECIA, MENORRHAGIA, CYSTITIS AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CYSTITIS, DYSMENORRHOEA, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS BLADDER, VAGINAL & URINARY TRACT INFECTION, MENORRHGAIA ARE ADDED. LOT NUMBER ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE/ DYSMENNORHEA (CRAMPING)"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEADACHE ("HEADACHE"), FEELING ABNORMAL ("BRAIN FOG"), MIGRAINE ("MIGRAINE"), ALOPECIA ("HAIR THINNING/HAIR LOSS"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE,"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) ") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTEROCTOMY /HYSTEROSCOPY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, HEADACHE, FEELING ABNORMAL, MIGRAINE, ALOPECIA, MENORRHAGIA, CYSTITIS AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CYSTITIS, DYSMENORRHOEA, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: PFS RECEIVED. INSERTION DATE UPDATED. EVENT VERBATIM UPDATED. INCIDENT 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEADACHE ("HEADACHE"), FEELING ABNORMAL ("BRAIN FOG"), MIGRAINE ("MIGRAINE"), INFECTION ("INFECTIONS") AND ALOPECIA ("HAIR THINNING"). THE PATIENT WAS TREATED WITH HYSTEROCTOMY TO REMOVE ESSURE IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, HEADACHE, FEELING ABNORMAL, MIGRAINE, INFECTION AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, FEELING ABNORMAL, HEADACHE, INFECTION, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889255 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R