BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10051745 · Received May 13, 2020

    Report

    Report Number
    2951250-2020-07228
    Event Type
    Injury
    Date Received
    May 13, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 919041, 904753) INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PER PATIENT COVER LETTER IN ESSURE INSERTION DATE: ON (B)(6) 2013. DISCREPANCY NOTED AS PER PATIENT COVER LETTER IN ESSURE REMOVAL DATE ON (B)(6) 2018. DISCREPANCY NOTED FOR ESSURE INSERTION DATE ON (B)(6) 2013 (PER PIF). DISCREPANCY NOTED FOR ESSURE REMOVAL DATE ON (B)(6) 2018 (PER PIF). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2020: FU3&4 PROCESS TOGETHER- PPF RECEIVED: PREVIOUSLY REPORTED EVENT- MEDICAL DEVICE REMOVAL WAS REPLACED WITH MENORRHAGIA, CONSUMER ADDRESS WERE UPDATED. 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUN-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 919041, 904753) INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PER PATIENT COVER LETTER IN ESSURE INSERTION DATE:-(B)(6) 2013 DISCREPANCY NOTED AS PER PATIENT COVER LETTER IN ESSURE REMOVAL DATE :-(B)(6) 2018. DISCREPANCY NOTED FOR ESSURE INSERTION DATE - (B)(6) 2013 (PER PIF). DISCREPANCY NOTED FOR ESSURE REMOVAL DATE- (B)(6) 2018 (PER PIF). LOT NUMBER: 904753 MANUFACTURE DATE:2011-10 EXPIRATION DATE: 2014-10 . LOT NUMBER: 919041 MANUFACTURE DATE:2011-11 EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-OCT-2020: QUALITY-SAFETY EVALUATION OF PTC. 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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
    514408 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 919041, 904753 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R