BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12114768 · Received July 5, 2021

    Report

    Report Number
    2951250-2021-02758
    Event Type
    Injury
    Date Received
    July 5, 2021
    Report Date
    July 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('EXCESSIVE BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL CYCLE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN, DYSPAREUNIA, HEADACHE, MIGRAINE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 2 COILS ON THE LEFT AND 3 COILS ON THE RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2017: RESULTS: NEGATIVE. LOT NUMBER: 882191 MANUFACTURING DATE:2011-07 EXPIRATION DATE:2014-07. 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 7-JUL-2021: 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('EXCESSIVE BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL CYCLE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN, DYSPAREUNIA, HEADACHE, MIGRAINE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 2 COILS ON THE LEFT AND 3 COILS ON THE RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2017: RESULTS: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JUN-2021: MEDICAL RECORD RECEIVED. REPORTER INFORMATION, PATIENT MEDICAL HISTORY AND REPORTER CAUSALITY COMMENT WAS 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
    1014655 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882191 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other