BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9303589 · Received November 11, 2019

    Report

    Report Number
    2951250-2019-11360
    Event Type
    Injury
    Date Received
    November 11, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('NICKEL ALLERGY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810675-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ALOPECIA ("HAIR LOSS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST VAGINAL INFECTION"), HEADACHE ("HEADACHE"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), GASTROINTESTINAL DISORDER ("GI CONDITIONS") AND HYPERSENSITIVITY ("ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, FATIGUE, ALOPECIA, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED, PELVIC PAIN, ABDOMINAL PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, GASTROINTESTINAL DISORDER AND HYPERSENSITIVITY HAD RESOLVED AND THE GASTROOESOPHAGEAL REFLUX DISEASE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BLADDER DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, HYPERSENSITIVITY, PELVIC PAIN, URINARY TRACT DISORDER, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFFS RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BLADDER PROBLEMS, URINARY TRACT DISORDER, FATIGUE, GI CONDITIONS, HAIR LOSS, WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2017: RIGHT AND LEFT FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: BILATERAL FALLOPIAN TUBES WITH NO PATHOLOGIC CHANGE. LOT NUMBER REPORTED ( 810675 ) IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2019: PLAINTIFF FACT SHEET WAS RECEIVED. EVENT ADDED FROM PFS- PELVIC PAIN, ABDOMINAL PAIN, BLADDER PROBLEMS, URINARY TRACT DISORDER, GI CONDITIONS, ALLERGY. EVENTS OUTCOMES WERE UPDATED. INCIDENT: NO VALID 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('NICKEL ALLERGY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810675-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ALOPECIA ("HAIR LOSS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST VAGINAL INFECTION") AND HEADACHE ("HEADACHE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED HAD RESOLVED AND THE FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, ALOPECIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2017: RIGHT AND LEFT FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: BILATERAL FALLOPIAN TUBES WITH NO PATHOLOGIC CHANGE.. LOT NUMBER REPORTED ( 810675 ) IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT NO VALID 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('NICKEL ALLERGY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810675) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ALOPECIA ("HAIR LOSS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST VAGINAL INFECTION") AND HEADACHE ("HEADACHE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED HAD RESOLVED AND THE FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, ALOPECIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2017: RIGHT AND LEFT FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: BILATERAL FALLOPIAN TUBES WITH NO PATHOLOGIC CHANGE.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PFS AND MR RECEIVED. REPORTERS INFORMATION UPDATED. LOT NO. WERE ADDED. EVENT: INJURY WERE UPDATED TO FATIGUE. NEW EVENTS: GERD, HAIR LOSS, INFECTION YEAST, NICKEL ALLERGY, HEADACHE , WEIGHT GAIN WERE ADDED. LAB DATA 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102042 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 810675-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R