BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9574561 · Received January 10, 2020

    Report

    Report Number
    2951250-2020-00393
    Event Type
    Injury
    Date Received
    January 10, 2020
    Report Date
    July 27, 2020
    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 ABDOMINAL PAIN LOWER ('RIGHT IS THE CRAMPING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CYST ("CYST") AND HAIR GROWTH ABNORMAL ("HAIR DOSEN'T' GROW"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, CYST AND HAIR GROWTH ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYST AND HAIR GROWTH ABNORMAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA: CYST, HAIR GROWTH DECREASED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUL-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 ABDOMINAL PAIN LOWER ('RIGHT IS THE CRAMPING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CYST ("CYST") AND HAIR GROWTH ABNORMAL ("HAIR DOESN'T' GROW"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, CYST AND HAIR GROWTH ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYST AND HAIR GROWTH ABNORMAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA: CYST, HAIR GROWTH DECREASED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-DEC-2019: THIS IS THE RETENTION CASE. ALL SOURCE DOCUMENT INFORMATION, REPORTER AND REFERENCE SECTION FROM DELETION CASE 2019-172935 ADDED TO THIS CASE. SOCIAL MEDIA RECEIVED: NEW EVENTS " CYST, "HAIR DOESN'T SEEN TO GROW" WAS ADDED. FOLLOW UP 2, 3, 4 AND 5 PROCESSED TOGETHER. ON 10-DEC-2019: FOLLOW UP 2, 3, 4 AND 5 PROCESSED TOGETHER. ON 2-JAN-2020: FOLLOW UP 2, 3, 4 AND 5 PROCESSED TOGETHER. 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
    38919 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R