BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9265184 · Received November 1, 2019

    Report

    Report Number
    2951250-2019-10978
    Event Type
    Injury
    Date Received
    November 1, 2019
    Report Date
    August 24, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('DYSMENORRHEA') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPROSCOPIC BILATERAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2018 (DISCREPANCY NOTED AS PER PIF). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-2020: MR RECEIVED. REPORTER INFORMATION, LOT NUMBER ADDED. EVENT MEDICAL DEVICE REMOVAL UPDATED TO EVENT DYSMENORRHEA. 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 DYSMENORRHOEA ('DYSMENORRHEA'). IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037), INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPROSCOPIC BILATERAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2018 (DISCREPANCY NOTED, AS PER PIF). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. LOT NUMBER#: 893037, MANUFACTURING DATE: 2011-08, EXPIRATION DATE: 2014-08. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-AUG-2020, QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 ('SURGERY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, 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 (TOTAL LAPAROSCOPIC BILATERAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY AND LAPAROSCOPIC ADHESIONS LYSIS AND LAPAROSCOPIC CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 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. 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-CONFORMANCE 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
    1059640 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R