BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9976542 · Received April 20, 2020

    Report

    Report Number
    2951250-2020-04625
    Event Type
    Injury
    Date Received
    April 20, 2020
    Report Date
    August 18, 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 ('CRAMP'). 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), ABDOMINAL DISTENSION ("STOMACH BLOATING"), HYPOAESTHESIA ("NUMBNESS IN RIGHT ARM"), RASH MACULAR ("FLUSHING IN RED PATCHES"), FATIGUE ("FATIGUED") AND HAIR COLOUR CHANGES ("STRIKES OF GRAY"). AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY, HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, HYPOAESTHESIA, RASH MACULAR, WEIGHT INCREASED, FATIGUE AND HAIR COLOUR CHANGES OUTCOME WAS UNKNOWN. AND THE ABDOMINAL DISTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, FATIGUE, HAIR COLOUR CHANGES, HYPOAESTHESIA, RASH MACULAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES WERE REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED VIA SOCIAL MEDIA: ABDOMINAL BLOATING. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: DUPLICATE CASE FOUND FOR SAME PATIENT. ALL THE INFORMATION, SOURCE DOCUMENT AND REFERENCES OF DELETION CASE (2020-134024) TRANSFERRED INTO RETENTION CASE-2019-230328. NEW REPORTER WAS ADDED. EVENT: FATIGUED, STRIKES OF GRAY HAIR GREYING. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ('CRAMP') 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), ABDOMINAL DISTENSION ("STOMACH BLOATING"), HYPOAESTHESIA ("NUMBNESS IN RIGHT ARM"), RASH MACULAR ("FLUSHING IN RED PATCHES"), FATIGUE ("FATIGUED") AND HAIR COLOUR CHANGES ("STRIKES OF GRAY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY, HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, HYPOAESTHESIA, RASH MACULAR, WEIGHT INCREASED, FATIGUE AND HAIR COLOUR CHANGES OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, FATIGUE, HAIR COLOUR CHANGES, HYPOAESTHESIA, RASH MACULAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES WERE REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED VIA SOCIAL MEDIA: ABDOMINAL BLOATING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-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 ('CRAMP') 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), ABDOMINAL DISTENSION ("STOMACH BLOATING"), HYPOAESTHESIA ("NUMBNESS IN RIGHT ARM") AND RASH MACULAR ("FLUSHING IN RED PATCHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, HYPOAESTHESIA, RASH MACULAR AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, HYPOAESTHESIA, RASH MACULAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES WERE REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED VIA SOCIAL MEDIA: ABDOMINAL BLOATING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: FU 3,4 & 5 PROCESS TOGETHER. ON 20-MAR-2020: FU 3,4 & 5 PROCESS TOGETHER. ON 20-MAR-2020: FU 3,4 & 5 PROCESS 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
    443183 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R