BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9009219 · Received September 12, 2019

    Report

    Report Number
    2951250-2019-06312
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    February 20, 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 MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') AND SJOGREN'S SYNDROME ('AUTOIMMUNE DISORDER TYPE OF DISORDER: SJOGRENS SYNDROME') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) 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 "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HERPES ("RASHES OR SKIN CONDITIONS TYPE: BREAKOUTS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL ALLERGY"), SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ANXIETY"), ANXIETY ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ANXIETY"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: POOR VISION"), ANAEMIA ("ANEMIA"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND ADHESION ("ADHESIONS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND GENITAL HAEMORRHAGE HAD RESOLVED, THE GENITAL HERPES OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, ALLERGY TO METALS, SJOGREN'S SYNDROME, MOOD SWINGS, ANXIETY, URINARY TRACT INFECTION, DEPRESSION, VISUAL IMPAIRMENT, ANAEMIA, UTERINE ENLARGEMENT, DYSMENORRHOEA AND ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADHESION, ALLERGY TO METALS, ANAEMIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, GENITAL HERPES, MENORRHAGIA, MOOD SWINGS, SJOGREN'S SYNDROME, URINARY TRACT INFECTION, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR MENORRHAGIA, GENERAL ABNORMAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-FEB-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') AND SJOGREN'S SYNDROME ('AUTOIMMUNE DISORDER TYPE OF DISORDER: SJOGRENS SYNDROME') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) 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 "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HERPES ("RASHES OR SKIN CONDITIONS TYPE: BREAKOUTS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL ALLERGY"), SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ANXIETY"), ANXIETY ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ANXIETY"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: POOR VISION"), ANAEMIA ("ANEMIA"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND ABDOMINAL ADHESIONS ("ADHESIONS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND GENITAL HAEMORRHAGE HAD RESOLVED, THE GENITAL HERPES OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, ALLERGY TO METALS, SJOGREN'S SYNDROME, MOOD SWINGS, ANXIETY, URINARY TRACT INFECTION, DEPRESSION, VISUAL IMPAIRMENT, ANAEMIA, UTERINE ENLARGEMENT, DYSMENORRHOEA AND ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, GENITAL HERPES, MENORRHAGIA, MOOD SWINGS, SJOGREN'S SYNDROME, URINARY TRACT INFECTION, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR MENORRHAGIA, GENERAL ABNORMAL BLEEDING QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-DEC-2019: PFS RECEIVED; LOT NO. WAS ADDED. NEW EVENTS-ABNORMAL BLEEDING (VAGINAL), NICKEL ALLERGY, SJOGRENS SYNDROME, MOOD SWINGS, ANXIETY, UTI, NICKEL ALLERGY, DEPRESSION,ABDOMEN PAIN, POOR VISION,ANEMIA, ENLARGED UTERUS, DYSMENORRHEA WERE ADDED & ONE EVENT WAS UPDATED FROM RASHES OR SKIN CONDITIONS TO BREAKOUTS. OUTCOMES WERE ADDED. REPORTERS 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE 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 "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH ("RASH") AND SKIN DISORDER ("SKIN CONDITION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE RASH AND SKIN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENORRHAGIA, RASH AND SKIN DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR MENORRHAGIA, GENERAL ABNORMAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED: PREVIOUSLY REPORTED EVENT INJURY WAS UPDATED TO NEW EVENTS MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, RASH, SKIN CONDITION,PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST NO LOT NUMBER WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA WAS CONDUCTED; 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
    810731 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R