BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11798050 · Received May 10, 2021

    Report

    Report Number
    2951250-2021-01796
    Event Type
    Injury
    Date Received
    May 10, 2021
    Report Date
    May 26, 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 RESPIRATORY DISORDER ('COMPLICATIONS OR FETAL ANOMALIES NOTED. INCLUDE RESPIRATORY PROBLEMS & INFECTION') AND RESPIRATORY TRACT INFECTION ('COMPLICATIONS OR FETAL ANOMALIES NOTED. INCLUDE RESPIRATORY PROBLEMS & INFECTION') IN A MALE PATIENT WHOSE MOTHER HAD INSERTED ESSURE (ESS205) (BATCH NO. 621814) DURING PREGNANCY. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE MOTHER HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH RESPIRATORY DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CONGENITAL ANOMALY) AND RESPIRATORY TRACT INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CONGENITAL ANOMALY). AT THE TIME OF THE REPORT, THE RESPIRATORY DISORDER AND RESPIRATORY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED RESPIRATORY DISORDER AND RESPIRATORY TRACT INFECTION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THIS CHILD CASE LINKED WITH MOTHER CASE (B)(4). LOT NUMBER: 621814 MANUFACTURE DATE: 2006-12 EXPIRATION DATE: 2008-11 . 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 25-MAY-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 RESPIRATORY DISORDER ('COMPLICATIONS OR FETAL ANOMALIES NOTED. INCLUDE RESPIRATORY PROBLEMS & INFECTION') AND RESPIRATORY TRACT INFECTION ('COMPLICATIONS OR FETAL ANOMALIES NOTED. INCLUDE RESPIRATORY PROBLEMS & INFECTION') IN A MALE PATIENT WHOSE MOTHER HAD INSERTED ESSURE (ESS205) (BATCH NO. 621814) DURING PREGNANCY. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE MOTHER HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH RESPIRATORY DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CONGENITAL ANOMALY) AND RESPIRATORY TRACT INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CONGENITAL ANOMALY). AT THE TIME OF THE REPORT, THE RESPIRATORY DISORDER AND RESPIRATORY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED RESPIRATORY DISORDER AND RESPIRATORY TRACT INFECTION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THIS CHILD CASE LINKED WITH MOTHER CASE (B)(4). 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
    692897 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 621814 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O