BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7250654 · Received February 8, 2018

    Report

    Report Number
    2951250-2018-00523
    Event Type
    Injury
    Date Received
    February 8, 2018
    Report Date
    April 28, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN JUST DOUBLED ME OVER') AND LOSS OF CONSCIOUSNESS ('PASSED OUT') 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), DIZZINESS ("DIZZINESS"), PYREXIA ("FEVER") AND TREMOR ("SHAKING"), 1095 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("WORSE BOWEL") AND MENORRHAGIA ("STILL HAVE PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTO WITH OVARIES LEFT.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, LOSS OF CONSCIOUSNESS, NAUSEA, VOMITING, DIZZINESS, PYREXIA, TREMOR AND GASTROINTESTINAL DISORDER HAD RESOLVED AND THE MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DIZZINESS, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, MENORRHAGIA, NAUSEA, PELVIC PAIN, PYREXIA, TREMOR AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: GASTROINTESTINAL DISORDER, STILL HAVE PERIODS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-NOV-2019: SOCIAL MEDIA RECEIVED. NEW EVENT ADDED: STILL HAVE PERIODS. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN JUST DOUBLED ME OVER") AND LOSS OF CONSCIOUSNESS ("PASSED OUT") 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, 1095 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), DIZZINESS ("DIZZINESS"), PYREXIA ("FEVER") AND TREMOR ("SHAKING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("WORSE BOWEL"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL IN SEPTEMBER). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, LOSS OF CONSCIOUSNESS, NAUSEA, VOMITING, DIZZINESS, PYREXIA, TREMOR AND GASTROINTESTINAL DISORDER HAD RESOLVED. THE REPORTER CONSIDERED DIZZINESS, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, NAUSEA, PELVIC PAIN, PYREXIA, TREMOR AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: GASTROINTESTINAL DISORDER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN JUST DOUBLED ME OVER') 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LOSS OF CONSCIOUSNESS ("PASSED OUT"), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), DIZZINESS ("DIZZINESS"), PYREXIA ("FEVER") AND TREMOR ("SHAKING"), 1095 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("WORSE BOWEL"), MENORRHAGIA ("STILL HAVE PERIODS"), ALOPECIA ("HAIR LOSS") AND NIGHT SWEATS ("NIGHT SWEAT EPISODES"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALP IN 2013, HYSTO WITH OVARIES LEFT ON (B)(6) 2018). ESSURE WAS REMOVED IN 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, LOSS OF CONSCIOUSNESS, NAUSEA, VOMITING, DIZZINESS, PYREXIA, TREMOR AND GASTROINTESTINAL DISORDER HAD RESOLVED AND THE MENORRHAGIA, ALOPECIA AND NIGHT SWEATS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DIZZINESS, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, MENORRHAGIA, NAUSEA, NIGHT SWEATS, PELVIC PAIN, PYREXIA, TREMOR AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER: (B)(4). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: GASTROINTESTINAL DISORDER, STILL HAVE PERIODS AND NIGHT SWEAT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED- NEW EVENT NIGHT SWEAT EPISODES WAS ADDED. REPORTER INFORMATION WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE 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 ('PAIN JUST DOUBLED ME OVER') 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LOSS OF CONSCIOUSNESS ("PASSED OUT"), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), DIZZINESS ("DIZZINESS"), PYREXIA ("FEVER") AND TREMOR ("SHAKING"), 1095 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("WORSE BOWEL"), MENORRHAGIA ("STILL HAVE PERIODS") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTO WITH OVARIES LEFT, BILATERAL SALP). ESSURE WAS REMOVED IN 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, LOSS OF CONSCIOUSNESS, NAUSEA, VOMITING, DIZZINESS, PYREXIA, TREMOR AND GASTROINTESTINAL DISORDER HAD RESOLVED AND THE MENORRHAGIA AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DIZZINESS, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, MENORRHAGIA, NAUSEA, PELVIC PAIN, PYREXIA, TREMOR AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: GASTROINTESTINAL DISORDER, STILL HAVE PERIODS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA WAS RECEIVED. EVENT ADDED- HAIR LOSS. REPORTER WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE 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 LOSS OF CONSCIOUSNESS ("PASSED OUT") 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, 1095 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN JUST DOUBLED ME OVER") (SERIOUSNESS CRITERION INTERVENTION REQUIRED), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), DIZZINESS ("DIZZINESS"), PYREXIA ("FEVER") AND TREMOR ("SHAKING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("WORSE BOWEL"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL IN (B)(6)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, LOSS OF CONSCIOUSNESS, NAUSEA, VOMITING, DIZZINESS, PYREXIA, TREMOR AND GASTROINTESTINAL DISORDER HAD RESOLVED. THE REPORTER CONSIDERED DIZZINESS, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, NAUSEA, PELVIC PAIN, PYREXIA, TREMOR AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER: (B)(4). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: GASTROINTESTINAL DISORDER . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: LAWYER WAS ADDED AS REPORTER. EVENT ADDED PER CONTENT FROM MEDICAL RECORDS (SOCIAL MEDIA): WORSE BOWEL. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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
    99020 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R