BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9130068 · Received September 27, 2019

    Report

    Report Number
    2951250-2019-08789
    Event Type
    Injury
    Date Received
    September 27, 2019
    Report Date
    April 2, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION ¿ OTHER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DEVICE MONITORING PROCEDURE NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), DYSMENORRHOEA ("DYSMENORRHEA (AS WRITTEN) (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS"), VAGINAL DISCHARGE ("VAG. DISCHARGE, OTHER"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, URINARY TRACT DISORDER, BLADDER DISORDER, VAGINAL DISCHARGE, FATIGUE, ALOPECIA, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PERFORATION, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. LOT NUMBER: 910512, MANUFACTURING DATE: 2011-10, EXPIRATION DATE: 2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION ¿ OTHER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DEVICE MONITORING PROCEDURE NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), DYSMENORRHOEA ("DYSMENORRHEA (AS WRITTEN) (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS"), VAGINAL DISCHARGE ("VAG. DISCHARGE, OTHER"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, URINARY TRACT DISORDER, BLADDER DISORDER, VAGINAL DISCHARGE, FATIGUE, ALOPECIA, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PERFORATION, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PLAINTIFF FACT SHEET RECEIVED. REPORTER AND MEDICAL HISTORY WERE ADDED. ESSURE LOT NUMBER ADDED. EVENT GENITAL HAEMORRHAGE WAS UPDATED AS NON SERIOUS. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION ¿ OTHER') AND GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DEVICE MONITORING PROCEDURE NOT PERFORMED". ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (AS WRITTEN) (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS"), VAGINAL DISCHARGE ("VAG. DISCHARGE, OTHER"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PERFORATION, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, URINARY TRACT DISORDER, BLADDER DISORDER, VAGINAL DISCHARGE, FATIGUE, ALOPECIA, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PERFORATION, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED - CASE BECOMES INCIDENT. PREVIOUSLY REPORTED EVENT INJURY NOS WAS REMOVED. NEW EVENTS DYSMENORRHEA (AS WRITTEN) (CRAMPING), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN. ABNORM. BLEED, BLADDER/URINARY PROBLEMS, VAG. DISCHARGE, FATIGUE, HAIR LOSS, NAUSEA, WEIGHT LOSS AND DEVICE MONITORING PROCEDURE NOT PERFORMED WAS ADDED. ESSURE INDICATION AND INSERTION DATE WAS ADDED. PATIENT DATE OF BIRTH WAS ADDED. NEW REPORTER AND CONSUMER ADDRESS WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922664 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910512 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other