BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9952630 · Received April 13, 2020

    Report

    Report Number
    2951250-2020-03484
    Event Type
    Injury
    Date Received
    April 13, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 CRAMPS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), MIGRAINE ("MIGRAINE"), FATIGUE ("TIRED"), MALAISE ("SICK"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA") AND VITAMIN D DEFICIENCY ("VIT D DEFICIENCY"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, MALAISE, ARTHRALGIA, FIBROMYALGIA AND VITAMIN D DEFICIENCY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, FATIGUE, FIBROMYALGIA, MALAISE, MIGRAINE, PELVIC PAIN AND VITAMIN D DEFICIENCY TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: MIGRAINE, CHRONIC PELVIC PAIN, TIRED, SICK, JOINT PAIN AND FIBROMYALGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUL-2020: MEDICAL RECORD RECEIVED NEW REPORTER INFORMATION AND LOT NO WAS 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 ('CHRONIC PELVIC CRAMPS'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932184-INV), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), MIGRAINE ("MIGRAINE"), FATIGUE ("TIRED"), MALAISE ("SICK"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA"). AND VITAMIN D DEFICIENCY ("VIT D DEFICIENCY"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, MALAISE, ARTHRALGIA, FIBROMYALGIA AND VITAMIN D DEFICIENCY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, FATIGUE, FIBROMYALGIA, MALAISE, MIGRAINE, PELVIC PAIN AND VITAMIN D DEFICIENCY TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: MIGRAINE, CHRONIC PELVIC PAIN, TIRED, SICK, JOINT PAIN AND FIBROMYALGIA. LOT#: REPORTED (932184) IS NOT VALID. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2020, QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('CHRONIC PELVIC CRAMPS') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), MIGRAINE ("MIGRAINE"), FATIGUE ("TIRED"), MALAISE ("SICK"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA") AND VITAMIN D DEFICIENCY ("VIT D DEFICIENCY"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, MALAISE, ARTHRALGIA, FIBROMYALGIA AND VITAMIN D DEFICIENCY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, FATIGUE, FIBROMYALGIA, MALAISE, MIGRAINE, PELVIC PAIN AND VITAMIN D DEFICIENCY TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: MIGRAINE, CHRONIC PELVIC PAIN, TIRED, SICK, JOINT PAIN AND FIBROMYALGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: REPORTER ADDED. CASE BECOME INCIDENT ESSURE REMOVAL DONE. ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: REPORTER ADDED. EVENT: VIT D DEFICIENCY ADDED. FU 3 AND 4 PROCESS TOGETHER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418827 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 932184-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R