BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10343365 · Received July 30, 2020

    Report

    Report Number
    2951250-2020-12531
    Event Type
    Injury
    Date Received
    July 30, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. IN 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2020: MR RECEIVED: EVENT MEDICAL DEVICE REMOVAL PT WAS UPDATED PELVIC PAIN. REPORTER ADDED. FOLLOW UP 3 AND 4 PROCESSED TOGETHER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 822308) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENORRHAGIA, MENSES IRREGULAR WITH EXCESSIVE BLEEDING, VAGINAL PAIN, IRON DEFICIENCY ANEMIA AND ACUTE VAGINITIS. IN 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: INSERTION DATE: (B)(6) 2007 (AS PER MR DISCREPANCY NOTED). INSERTION PROCEDURE: THE RIGHT TUBE WAS VISUALIZED FIRST, THE ESSURE IMPLANT WAS PLACED ON THE OPENING OF THE TUBE. THERE WERE FOUR COILS THAT WERE SEEN. THE SAME PROCEDURE WAS PERFORMED ON THE OTHER SIDE, ALSO WITH SOME DIFFICULTY, BECAUSE OF THE POSITION OF THE TUBE, BUT HE WAS ABLE TO PUT IT IN. I REMOVED THE TENACULUM FROM THE CERVIX AND FOUND THE PATIENT TO BE BLEEDING VERY HEAVILY FROM THE CERVIX. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2020: MR RECEIVED. REPORTER'S INFORMATION AND PATIENT RACE ADDED. PRODUCT'S INFORMATION AND LOT NO. WERE 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 822308- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENORRHAGIA, MENSES IRREGULAR WITH EXCESSIVE BLEEDING, VAGINAL PAIN, IRON DEFICIENCY ANEMIA AND ACUTE VAGINITIS. IN 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MENORRHAGIA ("MENORRHAGIA") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: INSERTION DATE: (B)(6) 2007 (AS PER MR DISCREPANCY NOTED). INSERTION PROCEDURE: THE RIGHT TUBE WAS VISUALIZED FIRST, THE ESSURE IMPLANT WAS PLACED ON THE OPENING OF THE TUBE. THERE WERE FOUR COILS THAT WERE SEEN. THE SAME PROCEDURE WAS PERFORMED ON THE OTHER SIDE, ALSO WITH SOME DIFFICULTY, BECAUSE OF THE POSITION OF THE TUBE, BUT HE WAS ABLE TO PUT IT IN. I REMOVED THE TENACULUM FROM THE CERVIX AND FOUND THE PATIENT TO BE BLEEDING VERY HEAVILY FROM THE CERVIX. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS PELVIC PAIN LOT # REPORTED (822308) IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2020: FOLLOW UP 6 & 7 PROCESSED TOGETHER .PIF RECEIVED :-EVENT MENORRHAGIA , ABNORMAL UTERINE BLEEDING , PAINFUL INTERCOURSE ADDED . REPORTER ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 MEDICAL DEVICE REMOVAL ('ESSURE REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. IN 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE (ESS205) WAS REMOVED IN 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2020: PIF RECEIVED: CASE WAS UPGRADED TO SERIOUS INCIDENT. EVENT INJURY WAS REPLACED WITH EVENT MEDICAL DEVICE REMOVAL. ESSURE REMOVAL DATE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809596 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 822308- NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R