BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6944328 · Received October 12, 2017

    Report

    Report Number
    2951250-2017-04626
    Event Type
    Injury
    Date Received
    October 12, 2017
    Report Date
    August 15, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VOMITING, PENICILLIN ALLERGY AND OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), NAUSEA ("NAUSEA"), HYPERSENSITIVITY ("ALLERGIC/HYPERSENSITIVITY REACTION: NERVE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), GASTRIC DISORDER ("GASTROINTESTINAL/DIGESTIVE SYSTEM CONDITION: STOMACH ISSUES"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL INFECTION ("INFECTION: UTI - VAGINAL"), MIGRAINE ("MIGRAINES"), PAIN IN EXTREMITY ("ABDOMINAL PAIN"), URINARY INCONTINENCE ("MIXED URINARY INCONTINENCE/ URINARY LEAKAGE INCOMPLETE"), URINARY RETENTION ("INCOMPLETE BLADDER EMPTYING"), RASH ("RASHES OR SKIN CONDITIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), URINARY TRACT INFECTION ("UTI"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY/FOCUS PAIN"), ARTHRALGIA ("HIP PAIN"), BACK PAIN ("LOWER BACK PAIN") AND SPINAL PAIN ("SPINE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY ON (B)(6) 2017). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, FATIGUE, HEADACHE, WEIGHT INCREASED, ABDOMINAL DISTENSION, VISUAL IMPAIRMENT, NAUSEA, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, GASTRIC DISORDER, HORMONE LEVEL ABNORMAL, VAGINAL INFECTION, MIGRAINE, PAIN IN EXTREMITY, URINARY INCONTINENCE, URINARY RETENTION, RASH, VAGINAL DISCHARGE, URINARY TRACT INFECTION, VISION BLURRED, ARTHRALGIA, BACK PAIN AND SPINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, RASH, SPINAL PAIN, URINARY INCONTINENCE, URINARY RETENTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS+MR RECEIVED: NEW EVENTS: HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, DYSMENORRHOEA, GASTRIC DISORDER, HORMONE LEVEL ABNORMAL, VAGINAL INFECTION, NAUSEA, URINARY INCONTINENCE, VAGINAL DISCHARGE, URINARY TRACT INFECTION, VISION BLURRED, BACK PAIN, ABDOMINAL PAIN, SPINAL PAIN, ARTHRALGIA, REPORTER, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT START DATE, STOP DATE, LOT NUMBER, LAB DATA, CONCOMITANT DISEASES WERE ADDED. 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.

    Additional Manufacturer Narrative · 0

    CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VOMITING, PENICILLIN ALLERGY AND OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VISUAL IMPAIRMENT ("VISION PROBLEMS"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC/HYPERSENSITIVITY REACTION: NERVE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), GASTRIC DISORDER ("GASTROINTESTINAL/DIGESTIVE SYSTEM CONDITION: STOMACH ISSUES"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL INFECTION ("INFECTION: UTI - VAGINAL"), NAUSEA ("NAUSEA"), MIXED INCONTINENCE ("MIXED URINARY INCONTINENCE/ URINARY LEAKAGE INCOMPLETE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), URINARY TRACT INFECTION ("UTI"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY/FOCUS PAIN"), BACK PAIN ("LOWER BACK PAIN"), SPINAL PAIN ("SPINE PAIN"), MIGRAINE ("MIGRAINES"), ARTHRALGIA ("HIP PAIN") WITH PAIN IN EXTREMITY, URINARY RETENTION ("INCOMPLETE BALDDER EMPTYING") AND RASH ("RASHES OR SKIN CONDITIONS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, VISUAL IMPAIRMENT, FATIGUE, HEADACHE, WEIGHT INCREASED, ABDOMINAL DISTENSION, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, GASTRIC DISORDER, HORMONE LEVEL ABNORMAL, VAGINAL INFECTION, NAUSEA, MIXED INCONTINENCE, VAGINAL DISCHARGE, URINARY TRACT INFECTION, VISION BLURRED, BACK PAIN, SPINAL PAIN, MIGRAINE, ARTHRALGIA, URINARY RETENTION AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MIGRAINE, MIXED INCONTINENCE, NAUSEA, RASH, SPINAL PAIN, URINARY RETENTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING") AND VISUAL IMPAIRMENT ("VISION PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY ON (B)(6) 2017). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, FATIGUE, HEADACHE, WEIGHT INCREASED, ABDOMINAL DISTENSION AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, FATIGUE, HEADACHE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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
    724755 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 904753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R