BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8886387 · Received August 13, 2019

    Report

    Report Number
    2951250-2019-04699
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    September 1, 2016
    Report Date
    May 7, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01970) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED BARRETT'S OESOPHAGUS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (ONE SIDE REMOVAL OF FALLOPIAN TUBE), U/L OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-AUG-2019: QUALITY SAFETY EVALUATION OF PTC. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 PAIN ('PAIN,PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01970) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED BARRETT'S OESOPHAGUS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA(HEAVY MENSTURAL BLEEDING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (ONE SIDE REMOVAL OF FALLOPIAN TUBE), U/L OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE DYSMENORRHOEA, ABDOMINAL PAIN AND HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, HEAVY MENSTRUAL BLEEDING AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF REMOVAL: (B)(6) 2017. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: NO NEW INFORMATION WAS RECEIVED, THEN MENTION THE UPDATE OF BOTH IMDRF/FDA CODES AS THE ONLY CHANGE. MR RECEIVED: REPORTER WAS ADDED, NO NEW CLINICALLY SIGNIFICANT INFORMATION WERE ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 PAIN ('PAIN,PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01970) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED BARRETT'S OESOPHAGUS. ON (B)(6)2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (ONE SIDE REMOVAL OF FALLOPIAN TUBE), U/L OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE DYSMENORRHOEA, ABDOMINAL PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF REMOVAL: (B)(6)2017. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-2019: PFS RECEIVED. REPORTERS INFORMATION UPDATED. EVENT: DYSMENORRHEA, MENORRHAGIA ,ABDOMINAL PAIN 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 PAIN ('PAIN.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01970) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED BARRETT'S OESOPHAGUS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (ONE SIDE REMOVAL OF FALLOPIAN TUBE), U/L OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-2019: PFS RECEIVED: EVENT INJURY WAS REPLACED WITH PAIN AND PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST. LOT NUMBER, MEDICAL HISTORY ADDED. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684390 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 D01970 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R