BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7097266 · Received December 7, 2017

    Report

    Report Number
    2951250-2017-10113
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    September 25, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) 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), ABDOMINAL PAIN LOWER ("CRAMPING"), RHEUMATOID ARTHRITIS ("AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), DIZZINESS ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: DIZZINESS"), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("LEG PAIN") AND ARTHRALGIA ("KNEES PAIN/ HIP PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, RHEUMATOID ARTHRITIS, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, DIZZINESS, BACK PAIN, PAIN IN EXTREMITY AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, PAIN IN EXTREMITY, PELVIC PAIN, RHEUMATOID ARTHRITIS, TOOTH DISORDER AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: IN (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2017: PATHOLOGY REPORT. GROSS DESCRIPTION: A. BILATERAL ESSURE DEVICE: RECEIVED IN FORMALIN ARE TWO METALLIC, SLIGHTLY WRINKLED WIRES RANGING IN LENGTH 17.5 TO 23.9 CM, AND HAVING AN AVERAGE DIAMETER OF LESS THAN 0.1 CM. ALSO RECEIVED ARE TWO METALLIC COILS RANGING IN LENGTH FROM 3.5 TO 4.1 CM AND HAVING AN AVERAGE DIAMETER OF 0.2 CM. FINAL DIAGNOSIS: BILATERAL ESSURE DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: NEW PFS RECEIVED- REPORTER, LOT NUMBER ADDED. NEW EVENTS : AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS, BLADDER OR URINARY PROBLEMS OR CHANGES, DENTAL PROBLEMS, DYSMENORRHEA(CRAMPING), DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE), NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: DIZZINESS, BACK PAIN, LEG PAIN, KNEES PAIN WERE ADDED. 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 ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) 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), ABDOMINAL PAIN LOWER ("CRAMPING"), RHEUMATOID ARTHRITIS ("AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DIZZINESS ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: DIZZINESS"), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("LEG PAIN") AND ARTHRALGIA ("KNEES PAIN/ HIP PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, RHEUMATOID ARTHRITIS, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, DIZZINESS, BACK PAIN, PAIN IN EXTREMITY AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, PAIN IN EXTREMITY, PELVIC PAIN, RHEUMATOID ARTHRITIS, TOOTH DISORDER AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2017 - PATHOLOGY REPORT: GROSS DESCRIPTION: BILATERAL ESSURE DEVICE: RECEIVED IN FORMALIN ARE TWO METALLIC, SLIGHTLY WRINKLED WIRES RANGING IN LENGTH 17.5 TO 23.9 CM, AND HAVING AN AVERAGE DIAMETER OF LESS THAN 0.1 CM. ALSO RECEIVED ARE TWO METALLIC COILS RANGING IN LENGTH FROM 3.5 TO 4.1 CM AND HAVING AN AVERAGE DIAMETER OF 0.2 CM. FINAL DIAGNOSIS: BILATERAL ESSURE DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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) AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (WILL HAVE SURGERY TO REMOVE THE ESSURE IMPLANT ON (B)(6) 2017.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY 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
    874608 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R