BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8056215 · Received November 9, 2018

    Report

    Report Number
    2951250-2018-04652
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    June 11, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF SALPINGECTOMY ('SALPINGECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: RAISON-PEYRON N, DU-THANH A, COMPAN C, PERROCHIA H, FRANCINI S, DUFLOS C, CROCHET P, NICKEL ALLERGY AND ADVERSE-EVENTS ATTRIBUTED TO ESSURE SYSTEM: IS THERE A LINK?, CONTACT DERMATITIS - CONGRESS OF THE EUROPEAN SOCIETY OF CONTACT DERMATITIS, 2018, 79:SUPPLEMENT 1 (36). ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SALPINGECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED DERMATITIS CONTACT ("CONTACT DERMATITIS"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE SALPINGECTOMY AND DERMATITIS CONTACT OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR SALPINGECTOMY WITH ESSURE. THE REPORTER CONSIDERED DERMATITIS CONTACT TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON AN UNKNOWN DATE: POSITIVE FOR NICKEL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. NICKEL DID NOT APPEAR TO BE RESPONSIBLE FOR THESE ADVERSE-EVENTS BECAUSE THERE WAS NO SIGNIFICANT DIFFERENCE, REGARDLESS OF THE SYMPTOMS IN THE PATIENTS WITH POSITIVE NICKEL PATCH TESTS VERSUS THAT IN THOSE WITH NEGATIVE RESULTS. EXTRACUTANEOUS SYMPTOMS AFTER ESSURE IMPLANTATION HAD THE HIGHEST PREVALENCE. SYSTEMIC CONTACT DERMATITIS TO NICKEL COULD NOT BE RULED OUT IN ONE CASE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2019: QUALITY SAFETY EVALUATION OF PTC. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 LITERATURE CASE DESCRIBES THE OCCURRENCE OF SALPINGECTOMY ("SALPINGECTOMY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: RAISON-PEYRON N, DU-THANH A, COMPAN C, PERROCHIA H, FRANCINI S, DUFLOS C, CROCHET P, NICKEL ALLERGY AND ADVERSE-EVENTS ATTRIBUTED TO ESSURE SYSTEM: IS THERE A LINK?, CONTACT DERMATITIS - CONGRESS OF THE EUROPEAN SOCIETY OF CONTACT DERMATITIS, 2018, 79:SUPPLEMENT 1 (36). ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SALPINGECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DERMATITIS CONTACT ("CONTACT DERMATITIS"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE SALPINGECTOMY AND DERMATITIS CONTACT OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR SALPINGECTOMY WITH ESSURE. THE REPORTER CONSIDERED DERMATITIS CONTACT TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON AN UNKNOWN DATE: POSITIVE FOR NICKEL. NICKEL DID NOT APPEAR TO BE RESPONSIBLE FOR THESE ADVERSE-EVENTS BECAUSE THERE WAS NO SIGNIFICANT DIFFERENCE, REGARDLESS OF THE SYMPTOMS IN THE PATIENTS WITH POSITIVE NICKEL PATCH TESTS VERSUS THAT IN THOSE WITH NEGATIVE RESULTS. EXTRACUTANEOUS SYMPTOMS AFTER ESSURE IMPLANTATION HAD THE HIGHEST PREVALENCE. SYSTEMIC CONTACT DERMATITIS TO NICKEL COULD NOT BE RULED OUT IN ONE CASE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894201 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R