BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7061608 · Received November 27, 2017

    Report

    Report Number
    2951250-2017-09007
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    May 1, 2012
    Report Date
    September 10, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("DEVICE HAD BEEN DAMAGED"), DEVICE DISLOCATION ("ESSURE DEVICE LOCATION OF DEVICE: STOMACH"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)"), PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, CAESAREAN SECTION AND PARITY 6. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGO ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE HAD BEEN DAMAGED'), DEVICE DISLOCATION ('ESSURE DEVICE LOCATION OF DEVICE: STOMACH'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS)'), PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, CAESAREAN SECTION AND PARITY 6. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGO ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: QUALITY-SAFETY EVALUATION OF PTC. 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("DEVICE HAD BEEN DAMAGED"), DEVICE DISLOCATION ("ESSURE DEVICE LOCATION OF DEVICE: STOMACH"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)"), PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, CAESAREAN SECTION AND PARITY 6. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGO ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE ON (B)(6) 2016. ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET- ALL RELEVANT MEDICAL HISTORY CONDITION, CONCURRENT CONDITION, CONCOMITANT MEDICATION, LOT NUMBER AND EVENTS DEVICE HAD BEEN DAMAGED, ESSURE DEVICE LOCATION OF DEVICE: STOMACH, DEVICE INEFFECTIVE, DEPRESSION WERE ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6), THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT UNDERWENT ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE ON (B)(6). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VULVOVAGINAL PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840539 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952109

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R IBUPROFEN| IBUPROFEN| IBUPROFEN| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]