BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11647010 · Received April 11, 2021

    Report

    Report Number
    2951250-2021-01160
    Event Type
    Injury
    Date Received
    April 11, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND SEIZURE ('SEIZURES') IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED BREAST DISCHARGE, BREAST TENDERNESS, GENERALIZED ANXIETY DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, ASTHMA, SINUSITIS, CESAREAN SECTION, ANXIETY DISORDER, CRYING, MOOD DEPRESSIONS AND URINARY TRACT INFECTION. DENIES ANY PROBLEMS WITH HEADACHES OR VISION CHANGES. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: KEPPRA, LEXAPRO AND XANAX. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, ESCITALOPRAM SINCE (B)(6) 2016, GABAPENTIN, OXCARBAZEPINE (OXCARBAZEPIN) AND PAROXETINE HYDROCHLORIDE (PAXIL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY"). AT THE TIME OF THE REPORT, THE ENDOMETRITIS, SEIZURE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, DEPRESSION, ANXIETY, DYSPAREUNIA, FATIGUE AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SEIZURE, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS- VAGINAL BLEEDING, MENORRHAGIA, PELVIC PAIN FEMALE, PSYCH INJURY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-APR-2021: 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 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND SEIZURE ('SEIZURES') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED BREAST DISCHARGE, BREAST TENDERNESS, GENERALIZED ANXIETY DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, ASTHMA, SINUSITIS, CESAREAN SECTION, ANXIETY DISORDER, CRYING, MOOD DEPRESSIONS AND URINARY TRACT INFECTION. DENIES ANY PROBLEMS WITH HEADACHES OR VISION CHANGES. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: KEPPRA, LEXAPRO AND XANAX. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, ESCITALOPRAM SINCE (B)(6) 2016, GABAPENTIN, OXCARBAZEPINE (OXCARBAZEPIN) AND PAROXETINE HYDROCHLORIDE (PAXIL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY"). AT THE TIME OF THE REPORT, THE ENDOMETRITIS, SEIZURE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, DEPRESSION, ANXIETY, DYSPAREUNIA, FATIGUE AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SEIZURE, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS- VAGINAL BLEEDING, MENORRHAGIA, PELVIC PAIN FEMALE, PSYCH INJURY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-APR-2021: MR RECEIVED: EVENT CHRONIC ENDOMETRITIS ADDED AND MADE MEDICALLY SIGNIFICANT. REPORTER, MEDICAL HISTORY AND HISTORICAL DRUG 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
    544074 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822376 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other ALPRAZOLAM| ALPRAZOLAM| ESCITALOPRAM| ESCITALOPRAM| GABAPENTIN| GABAPENTIN| OXCARBAZEPIN| OXCARBAZEPIN| PAXIL [PAROXETINE HYDROCHLORIDE]| PAXIL [PAROXETINE HYDROCHLORIDE]