BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11027677 · Received December 17, 2020

    Report

    Report Number
    2951250-2020-15869
    Event Type
    Injury
    Date Received
    December 17, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEED.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), BACK PAIN ("BACK PAIN / OTHER."), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), URINARY TRACT INFECTION ("UTI"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEM"), MIGRAINE ("MIGRAINES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, BACK PAIN, VAGINAL DISCHARGE, URINARY TRACT INFECTION, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, MIGRAINE, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MIGRAINE, NAUSEA, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR THE FOLLOWING EVENTS BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE, UTI, GI CONDITIONS, HAIR LOSS, DENTAL PROBS., MIGRAINES, NAUSEA AND WEIGHT LOSS. NO REMOVAL PLANNED:UNABLE TO AFFORD SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: BILATERAL ESSURE IMPLANTS APPEAR TO BE IN SATISFACTORY POSITION, AND THERE IS EVIDENCE OF BILATERAL TUBAL OCCLUSION.. IMAGING PROCEDURE - ON (B)(6) 2011: ESSURE CONFIRMATION TEST: RESULT NOT PROVIDED. LOT NUMBER: 810890, MANUFACTURE DATE: 2010-12, EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-DEC-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEED.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), BACK PAIN ("BACK PAIN / OTHER."), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), URINARY TRACT INFECTION ("UTI"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEM"), MIGRAINE ("MIGRAINES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, BACK PAIN, VAGINAL DISCHARGE, URINARY TRACT INFECTION, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, MIGRAINE, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MIGRAINE, NAUSEA, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR THE FOLLOWING EVENTS BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE, UTI, GI CONDITIONS, HAIR LOSS, DENTAL PROBS., MIGRAINES, NAUSEA AND WEIGHT LOSS. NO REMOVAL PLANNED:UNABLE TO AFFORD SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2011: BILATERAL ESSURE IMPLANTS APPEAR TO BE IN SATISFACTORY POSITION, AND THERE IS EVIDENCE OF BILATERAL TUBAL OCCLUSION. IMAGING PROCEDURE ON (B)(6) 2011: ESSURE CONFIRMATION TEST: RESULT NOT PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2020: PLAINTIFF FACT SHEET RECEIVED. REPORTER ADDED. ESSURE LOT NUMBER ADDED. LAB DATA 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
    1493686 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 810890 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other