BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9516139 · Received December 24, 2019

    Report

    Report Number
    2951250-2019-14264
    Event Type
    Injury
    Date Received
    December 24, 2019
    Report Date
    February 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('I HAD PARTIAL HYSTERECTOMY ,IM JUST SHY 4 MONTHS POST HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HYPOTHYROIDISM ("I HAVE HYPOTHYROID, BUT M HOPING MY NEW THYROID MEDS WILL LACK IN SO I CAN HAVE SOME KIND OF ENERGY THIS SUMMER") AND SLUGGISHNESS ("I FEEL SLUGGISH STILL"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HYPOTHYROIDISM AND SLUGGISHNESS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYPOTHYROIDISM, MEDICAL DEVICE REMOVAL AND SLUGGISHNESS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: I HAD PARTIAL HYSTERECTOMY, I¿M JUST SHY 4 MONTHS POST HYSTERECTOMY, I FEEL SLUGGISH STILL, I HAVE HYPOTHYROID, BUT M HOPING MY NEW THYROID MEDS WILL LACK IN SO I CAN HAVE SOME KIND OF ENERGY THIS SUMMER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-FEB-2020: QUALITY SAFETY EVALUATION OF PTC. PREVIOUSLY ADDED EVENT HYPOTHYROIDISM WAS UPDATED TO BE NON-SERIOUS. 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 MEDICAL DEVICE REMOVAL ('I HAD PARTIAL HYSTERECTOMY, IM JUST SHY 4 MONTHS POST HYSTERECTOMY') AND HYPOTHYROIDISM ('I HAVE HYPOTHYROID, BUT M HOPING MY NEW THYROID MEDS WILL LACK IN SO I CAN HAVE SOME KIND OF ENERGY THIS SUMMER') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HYPOTHYROIDISM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FEELING ABNORMAL ("I FEEL SLUGGISH STILL"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HYPOTHYROIDISM AND FEELING ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FEELING ABNORMAL, HYPOTHYROIDISM AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: I HAD PARTIAL HYSTERECTOMY, I¿M JUST SHY 4 MONTHS POST HYSTERECTOMY, I FEEL SLUGGISH STILL, I HAVE HYPOTHYROID, BUT M HOPING MY NEW THYROID MEDS WILL LACK IN SO I CAN HAVE SOME KIND OF ENERGY THIS SUMMER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311402 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R