BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9933889 · Received April 8, 2020

    Report

    Report Number
    2951250-2020-02808
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    October 1, 2012
    Report Date
    October 22, 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 PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION') AND PELVIC PAIN ('SEVERE AND PERSISTENT PELVIC CRAMPING AND PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACK PAIN ("LOW BACK PAIN"). IN 2015, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE"). IN 2016, THE PATIENT EXPERIENCED KNEE PAIN ("KNEE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFECTION ("CONSTANT INFECTIONS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN HIP ("HIP PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2019(TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, KNEE PAIN, INFECTION, ABDOMINAL PAIN AND PAIN IN HIP WAS RESOLVING AND THE MENSTRUATION IRREGULAR, BACK PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, HEADACHE, INFECTION, KNEE PAIN, MENSTRUATION IRREGULAR, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND PAIN IN HIP TO BE RELATED TO ESSURE. LOT NUMBER: 940971. MANUFACTURING DATE: 2012-01. EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION') AND PELVIC PAIN ('SEVERE AND PERSISTENT PELVIC CRAMPING AND PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACK PAIN ("LOW BACK PAIN"). IN 2015, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE"). IN 2016, THE PATIENT EXPERIENCED KNEE PAIN ("KNEE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFECTION ("CONSTANT INFECTIONS"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), PAIN IN HIP ("HIP PAIN") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2019(TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, KNEE PAIN, INFECTION, ABDOMINAL PAIN AND PAIN IN HIP WAS RESOLVING AND THE MENSTRUATION IRREGULAR, BACK PAIN, HEADACHE AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, KNEE PAIN, MENSTRUATION IRREGULAR, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND PAIN IN HIP TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE AND REMOVAL DATE- (B)(6) 2012 AND (B)(6)2019 LOT NUMBER: 940971, MANUFACTURING DATE: 2012-01, EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2020: PIF RECEIVED- NEW EVENT IRREGULAR BLEEDING WAS ADDED. REPORTER INFORMATION WAS 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION') AND PELVIC PAIN ('SEVERE AND PERSISTENT PELVIC CRAMPING AND PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACK PAIN ("LOW BACK PAIN"). IN 2015, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE"). IN 2016, THE PATIENT EXPERIENCED KNEE PAIN ("KNEE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFECTION ("CONSTANT INFECTIONS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN HIP ("HIP PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2019 (TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, KNEE PAIN, INFECTION, ABDOMINAL PAIN AND PAIN IN HIP WAS RESOLVING AND THE MENSTRUATION IRREGULAR, BACK PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, HEADACHE, INFECTION, KNEE PAIN, MENSTRUATION IRREGULAR, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND PAIN IN HIP TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAR-2020: PFS AN MR RECEIVED: CASE BECOME INCIDENT. LOT NUMBER ADDED EVENTS: IRREGULAR PERIODS, LOW BACK PAIN KNEE PAIN, SEVERE AND PERSISTENT PELVIC CRAMPING, HEADACHES, PELVIC INFLAMMATION, CONSTANT INFECTIONS, ABDOMINAL PAIN, HIP PAIN, SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST WERE ADDED. EVENT ONSET DATE, OUTCOME, REPORTERS, PATIENT DEMOGRAPHICS WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405257 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940971 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R