BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10020881 · Received May 4, 2020

    Report

    Report Number
    2951250-2020-06644
    Event Type
    Injury
    Date Received
    May 4, 2020
    Date of Event
    January 1, 2012
    Report Date
    May 14, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('RIGHT SIDE PELVIC PAIN/ STABBING PAIN LASTS FOR 10-15 MINS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED CESAREAN SECTION, WISDOM TEETH REMOVAL, HYPERTENSION, MIGRAINE, SEASONAL ALLERGY, DYSPLASIA (INFANT), BUTTOCK PAIN (RIGHT), SCIATICA (RIGHT), LOW BACK PAIN AND SPONDYLOARTHROPATHY. CONCURRENT CONDITIONS INCLUDED PAIN IN HIP, SKIN TAGS AND DYSURIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) / CRAMPS"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)/UTI MULTIPLE"). IN 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION BLADDER"). THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), LACTOBACILLUS ACIDOPHILUS AND SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY,CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA AND CYSTITIS HAD RESOLVED, THE URINARY TRACT INFECTION, ANXIETY AND FATIGUE WAS RESOLVING AND THE WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, CYSTITIS, DYSMENORRHOEA, FATIGUE, PELVIC PAIN, URINARY TRACT INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2020: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('RIGHT SIDE PELVIC PAIN/ STABBING PAIN LASTS FOR 10-15 MINS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED CESAREAN SECTION, WISDOM TEETH REMOVAL, HYPERTENSION, MIGRAINE, SEASONAL ALLERGY, DYSPLASIA (INFANT), BUTTOCK PAIN (RIGHT), SCIATICA (RIGHT), LOW BACK PAIN AND JOINT DYSFUNCTION. CONCURRENT CONDITIONS INCLUDED PAIN IN HIP, SKIN TAGS AND DYSURIA. IN 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) / CRAMPS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)/UTI MULTIPLE"). IN 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION BLADDER"). THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), LACTOBACILLUS ACIDOPHILUS AND SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY,CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA AND CYSTITIS HAD RESOLVED, THE URINARY TRACT INFECTION, ANXIETY AND FATIGUE WAS RESOLVING AND THE WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, CYSTITIS, DYSMENORRHOEA, FATIGUE, PELVIC PAIN, URINARY TRACT INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-APR-2020: PFS AND MR RECEIVED. CASE BECAME VALID AND SERIOUS INCIDENT. LOT NUMBER ADDED. PREVIOUSLY REPORTED EVENT OF INJURY UPDATED TO PELVIC PAIN. NEW EVENTS: UTI , ANXIETY, DYSMENORRHEA (CRAMPING), FATIGUE, WEIGHT GAIN, INFECTION BLADDER AND SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST. NEW REPORTER, PATIENT DETAILS AND DATE OF REMOVAL LAB TEST, MEDICAL HISTORY AND CONCOMITANT CONDITIONS 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
    484797 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822374 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R