BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6908581 · Received October 2, 2017

    Report

    Report Number
    2951250-2017-04129
    Event Type
    Injury
    Date Received
    October 2, 2017
    Report Date
    February 26, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN / SEVERE PAIN') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC DISCOMFORT ("DISCOMFORT"), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ANXIETY ("ANXIETY") AND RASH ("FREQUENT RASHES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC DISCOMFORT, MENORRHAGIA, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, ANXIETY AND RASH HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, PELVIC DISCOMFORT, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SUBSEQUENTLY SOUGHT TREATMENT FOR HER SYMPTOMS BUT WAS UNABLE TO RESOLVE HER SYMPTOMS. PLAINTIFF NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COILS WERE PROPERLY PLACED. LOT NUMBER: 940970 MANUFACTURING DATE: 2012/01 EXPIRATION DATE: 2015/01. 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 25-FEB-2021: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN / SEVERE PAIN') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC DISCOMFORT ("DISCOMFORT"), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ANXIETY ("ANXIETY") AND RASH ("FREQUENT RASHES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC DISCOMFORT, MENORRHAGIA, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, ANXIETY AND RASH HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, PELVIC DISCOMFORT, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SUBSEQUENTLY SOUGHT TREATMENT FOR HER SYMPTOMS BUT WAS UNABLE TO RESOLVE HER SYMPTOMS. PLAINTIFF NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COILS WERE PROPERLY PLACED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-FEB-2021: REPORTER AND LOT NUMBER ADDED FROM MR. 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 ("CHRONIC PELVIC PAIN / SEVERE PAIN") IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DISCOMFORT ("DISCOMFORT"), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ANXIETY ("ANXIETY") AND RASH ("FREQUENT RASHES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DISCOMFORT, MENORRHAGIA, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, ANXIETY AND RASH HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DISCOMFORT, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SUBSEQUENTLY SOUGHT TREATMENT FOR HER SYMPTOMS BUT WAS UNABLE TO RESOLVE HER SYMPTOMS. PLAINTIFF NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COILS WERE PROPERLY PLACED. 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
    688538 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940970

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R