BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 10419312 · Received August 18, 2020

    Report

    Report Number
    2951250-2020-13337
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Report Date
    August 31, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('METALLIC FRAGMENTS ARE IDENTIFIED IN THE LEFT LOWER GLUTEUS MUSCLE.'), UTERINE PERFORATION ('THE LEFT-SIDED TUBAL LIGATION DEVICE HAS PENETRATED THE LEFT UTERINE FUNDUS') AND DEVICE DISLOCATION ('METALLIC FRAGMENTS ARE IDENTIFIED IN THE LEFT LOWER GLUTEUS MUSCLE.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12242287) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE EXPULSION ("MIGRATION, MIGRATION OF THE LEFT TUBAL LIGATION DEVICE INTO THE LEFT ENDOMETRIAL CAVITY"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION AND UTERINE PERFORATION TO BE RELATED TO ESSURE (ESS205). LOT NUMBER:12242287, MANUFACTURING DATE:2003/08, EXPIRATION DATE:2004/10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 DEVICE BREAKAGE ('METALLIC FRAGMENTS ARE IDENTIFIED IN THE LEFT LOWER GLUTEUS MUSCLE.'), UTERINE PERFORATION ('THE LEFT-SIDED TUBAL LIGATION DEVICE HAS PENETRATED THE LEFT UTERINE FUNDUS') AND DEVICE DISLOCATION ('METALLIC FRAGMENTS ARE IDENTIFIED IN THE LEFT LOWER GLUTEUS MUSCLE.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12242287) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE EXPULSION ("MIGRATION, MIGRATION OF THE LEFT TUBAL LIGATION DEVICE INTO THE LEFT ENDOMETRIAL CAVITY"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION AND UTERINE PERFORATION TO BE RELATED TO ESSURE (ESS205). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-JUL-2020: MEDICAL RECORD RECEIVED LOT NUMBER WAS ADDED. EVENTS "THE LEFT-SIDED TUBAL LIGATION DEVICE HAS PENETRATED THE LEFT UTERINE FUNDUS AND METALLIC FRAGMENTS ARE IDENTIFIED IN THE LEFT LOWER GLUTEUS MUSCLE." WERE ADDED. MEDICAL HISTORY AND REPORTER INFORMATION WERE ADDED. 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
    885803 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 12242287 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other