BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18265216 · Received December 5, 2023

    Report

    Report Number
    2951250-2023-03499
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    September 22, 2016
    Report Date
    February 5, 2024
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D23515) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. THE PATIENT HAD A MEDICAL HISTORY OF CHICKENPOX, RHEUMATOID ARTHRITIS, HEARTBURN, HEMORRHOIDS, ABDOMINAL PAIN, GALACTORRHEA, BREAST TENDERNESS, INCREASED APPETITE, NAUSEA, WEIGHT GAIN, PREGNANCY AND NICKEL ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DEPO PROVERA. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 22 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (OPERATIVE LAPAROSCOPY BILATERAL SALPINGECTOMY). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE RIGHT TUBE HAD 4 COILS AND RIGHT TUBE HAD 8 COILS. LOT NUMBER: D23515 MANUFACTURE DATE: 2014-08 EXPIRATION DATE: 2017-08. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-FEB-2024: 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.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D23515) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF CHICKENPOX, RHEUMATOID ARTHRITIS, HEARTBURN, HEMORRHOIDS, ABDOMINAL PAIN, GALACTORRHEA, BREAST TENDERNESS, INCREASED APPETITE, NAUSEA, WEIGHT GAIN, PREGNANCY AND NICKEL ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DEPO PROVERA. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 22 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (OPERATIVE LAPAROSCOPY BILATERAL SALPINGECTOMY). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE RIGHT TUBE HAD 4 COILS AND RIGHT TUBE HAD 8 COILS. 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
    2232678 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 D23515 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention