BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9486439 · Received December 18, 2019

    Report

    Report Number
    2951250-2019-13183
    Event Type
    Injury
    Date Received
    December 18, 2019
    Report Date
    December 30, 2019
    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 PELVIC PAIN ('STILL IN A TON OF PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("STILL EXTREMELY BLOATED"), RASH ("BURN RASH"), ACNE ("HAD NO IDEA ESSURE WAS CAUSING ME THIS TOO - ACNE"), SKIN LESION ("HAD NO IDEA ESSURE WAS CAUSING ME THIS TOO - HEAD SCABS"), SKIN ODOUR ABNORMAL ("HAD NO IDEA ESSURE WAS CAUSING ME THIS TOO - HEAD ODOUR"), FIBROMYALGIA ("FIBROMYALGIA"), AUTONOMIC NERVOUS SYSTEM IMBALANCE ("DYSAUTONOMIA"), OVARIAN CYST ("CYST ON MY RIGHT OVARY"), VULVOVAGINAL PAIN ("ACHE IN MY VAGINAL AREA") AND MALAISE ("SICK"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, FIBROMYALGIA AND AUTONOMIC NERVOUS SYSTEM IMBALANCE HAD NOT RESOLVED AND THE RASH, ACNE, SKIN LESION, SKIN ODOUR ABNORMAL, OVARIAN CYST, VULVOVAGINAL PAIN AND MALAISE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ACNE, AUTONOMIC NERVOUS SYSTEM IMBALANCE, FIBROMYALGIA, MALAISE, OVARIAN CYST, PELVIC PAIN, RASH, SKIN LESION, SKIN ODOUR ABNORMAL AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: HAD NO IDEA THAT ESSURE WAS CAUSING THIS TOO - ACNE, HEAD SCABS AND WEIRD HEAD ODOR, ABDOMINAL DISTENSION, PELVIC PAIN, FIBROMYALGIA AND AUTONOMIC NERVOUS SYSTEM IMBALANCE, RIGHT OVARIAN CYST, VULVOVAGINAL PAIN, BURN RASH. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-DEC-2019: SOCIAL MEDIA RECEIVED: EVENT SICK WAS ADDED. NO 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 PELVIC PAIN ('STILL IN A TON OF PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("STILL EXTREMELY BLOATED"), RASH ("BURN RASH"), ACNE ("HAD NO IDEA ESSURE WAS CAUSING ME THIS TOO - ACNE"), SKIN LESION ("HAD NO IDEA ESSURE WAS CAUSING ME THIS TOO - HEAD SCABS"), SKIN ODOUR ABNORMAL ("HAD NO IDEA ESSURE WAS CAUSING ME THIS TOO - HEAD ODOUR"), FIBROMYALGIA ("FIBROMYALGIA"), AUTONOMIC NERVOUS SYSTEM IMBALANCE ("DYSAUTONOMIA"), OVARIAN CYST ("CYST ON MY RIGHT OVARY") AND VULVOVAGINAL PAIN ("ACHE IN MY VAGINAL AREA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, FIBROMYALGIA AND AUTONOMIC NERVOUS SYSTEM IMBALANCE HAD NOT RESOLVED AND THE RASH, ACNE, SKIN LESION, SKIN ODOUR ABNORMAL, OVARIAN CYST AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ACNE, AUTONOMIC NERVOUS SYSTEM IMBALANCE, FIBROMYALGIA, OVARIAN CYST, PELVIC PAIN, RASH, SKIN LESION, SKIN ODOUR ABNORMAL AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: HAD NO IDEA THAT ESSURE WAS CAUSING THIS TOO ACNE, HEAD SCABS AND WEIRD HEAD ODOR, ABDOMINAL DISTENSION, PELVIC PAIN, FIBROMYALGIA AND AUTONOMIC NERVOUS SYSTEM IMBALANCE, RIGHT OVARIAN CYST, VULVOVAGINAL PAIN, BURN RASH. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-DEC-2019: SOCIAL MEDIA RECEIVED. THIS CASE BECAME INCIDENT. NEW EVENTS ADDED- ABDOMINAL DISTENSION, PELVIC PAIN, FIBROMYALGIA, RIGHT OVARIAN CYST, VULVOVAGINAL PAIN, BURN RASH AND AUTONOMIC NERVOUS SYSTEM IMBALANCE. NO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280290 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R