BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 15316509 · Received August 29, 2022

    Report

    Report Number
    2951250-2022-01035
    Event Type
    Injury
    Date Received
    August 29, 2022
    Report Date
    September 13, 2022
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A PATIENT AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('THE FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THIS TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. SINCE THEN, I HAVE HAD FOLLOW-UP TREATMENTS AND THE FOREIGN-BODY MATERIAL HAS BEEN REMOVED. AS A RESULT OF THE SYMPTOMS, I AM HINDERED IN MY NORMAL DAILY FUNCTIONING, AND I SUFFER DAMAGES. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2022: THE CASE (B)(4) WILL BE DELETED FROM BAYER PV DATABASE. NULLIFICATION REASON: THIS CASE WAS IDENTIFIED AS A DUPLICATE CASE FROM CASE (B)(4) TO WHICH ALL INFORMATION WAS TRANSFERRED. ON 1-SEP-2022: QUALITY SAFETY EVALUATION OF PTC. ON 5-SEP-2022: HA REFERENCE NUMBER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("THE FOREIGN-BODY MATERIAL HAS BEEN REMOVED") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: AFTER THIS TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. SINCE THEN, I HAVE HAD FOLLOW-UP TREATMENTS AND THE FOREIGN-BODY MATERIAL HAS BEEN REMOVED. AS A RESULT OF THE SYMPTOMS, I AM HINDERED IN MY NORMAL DAILY FUNCTIONING, AND I SUFFER DAMAGES. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269474 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention