BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12127546 · Received July 7, 2021

    Report

    Report Number
    2951250-2021-02782
    Event Type
    Injury
    Date Received
    July 7, 2021
    Report Date
    July 9, 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 HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508015) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE FIBROID, CHRONIC ANEMIA AND PELVIC PAIN. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HEAVY MENSTRUAL BLEEDING TO BE RELATED TO ESSURE (ESS205). LOT NUMBER:508015. MANUFACTURING DATE:2005-09. EXPIRATION DATE:2007-03. 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 9-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 HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508015) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE FIBROID, CHRONIC ANEMIA AND PELVIC PAIN. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HEAVY MENSTRUAL BLEEDING TO BE RELATED TO ESSURE (ESS205). 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
    1025626 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 508015 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R