BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10020071 · Received May 4, 2020

    Report

    Report Number
    2951250-2020-06605
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 29-APR-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-MAY-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("LOW BACK PAIN") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (EXTRACTION OF ESSURE WITH LAPAROSCOPY AND HYSTEROSCOPY, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCHEDULED EXTRACTION OF THE ESSURE METHOD IN THE OPERATING ROOM BY LAPAROSCOPY AND HYSTEROSCOPY, WITH BILATERAL SALPINGECTOMY AND RADIOLOGICAL VERIFICATION OF COMPLETE EXTRACTION OF BOTH DEVICES, DUE TO COMPATIBLE SYMPTOMS REPORTED BY THE PATIENT: LOW BACK AND PELVIC PAIN, MIGRAINES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: VERIFICATION OF COMPLETE EXTRACTION OF BOTH DEVICES. LOT NUMBER:880437 MANUFACTURING DATE:2011-07 EXPIRATION DATE:2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2020: INSERTION DATE ADDED. 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.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 29-APR-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-MAY-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("LOW BACK PAIN") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (EXTRACTION OF ESSURE WITH LAPAROSCOPY AND HYSTEROSCOPY, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCHEDULED EXTRACTION OF THE ESSURE METHOD IN THE OPERATING ROOM BY LAPAROSCOPY AND HYSTEROSCOPY, WITH BILATERAL SALPINGECTOMY AND RADIOLOGICAL VERIFICATION OF COMPLETE EXTRACTION OF BOTH DEVICES, DUE TO COMPATIBLE SYMPTOMS REPORTED BY THE PATIENT: LOW BACK AND PELVIC PAIN, MIGRAINES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: VERIFICATION OF COMPLETE EXTRACTION OF BOTH DEVICES. LOT NUMBER: 880437, MANUFACTURING DATE: 2011-07, EXPIRATION DATE:2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAY-2020: QUALITY SAFETY EVALUATION OF PTC. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("LOW BACK PAIN") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (EXTRACTION OF ESSURE WITH LAPAROSCOPY AND HYSTEROSCOPY, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCHEDULED EXTRACTION OF THE ESSURE METHOD IN THE OPERATING ROOM BY LAPAROSCOPY AND HYSTEROSCOPY, WITH BILATERAL SALPINGECTOMY AND RADIOLOGICAL VERIFICATION OF COMPLETE EXTRACTION OF BOTH DEVICES, DUE TO COMPATIBLE SYMPTOMS REPORTED BY THE PATIENT: LOW BACK AND PELVIC PAIN, MIGRAINES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON AN UNKNOWN DATE: VERIFICATION OF COMPLETE EXTRACTION OF BOTH DEVICES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483760 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 880437 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R