BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8829880 · Received July 26, 2019

    Report

    Report Number
    2951250-2019-04203
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    December 1, 2014
    Report Date
    July 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 851385- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST (LEFT), NECK PAIN, POST COITAL BLEEDING, ANXIETY DISORDER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS SINCE 2008 TO (B)(6) 2013 FOR BIRTH CONTROL. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEM"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASHES OR SKIN CONDITIONS TYPE"), SKIN DISORDER ("SKIN CONDITION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES / HEADACHES") AND ALOPECIA ("HAIR LOSS"). IN 2017, THE PATIENT EXPERIENCED EYE DISORDER ("VISION / EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND SCIATICA ("SCIATIC NERVE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY) AND CLEANING AND FILLING. ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, RASH, SKIN DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, TOOTH DISORDER, EYE DISORDER, VISUAL IMPAIRMENT, WEIGHT FLUCTUATION, FATIGUE, SCIATICA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, FATIGUE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, SCIATICA, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: TRAILING COIL LEFT- 5, RIGHT- 5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM PATIENT¿S MEDICAL RECORD : BACK PAIN, ABDOMINAL PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: UPDATE OF INFORMATION (BATCH IS INVALID). 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 PELVIC PAIN ('PELVIC PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 851385) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST (LEFT), NECK PAIN, POST COITAL BLEEDING, ANXIETY DISORDER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS SINCE 2008 TO (B)(6) 2013 FOR BIRTH CONTROL. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEM"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASHES OR SKIN CONDITIONS TYPE"), SKIN DISORDER ("SKIN CONDITION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES / HEADACHES") AND ALOPECIA ("HAIR LOSS"). IN 2017, THE PATIENT EXPERIENCED EYE DISORDER ("VISION / EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND SCIATICA ("SCIATIC NERVE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY) AND CLEANING AND FILLING. ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, RASH, SKIN DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, TOOTH DISORDER, EYE DISORDER, VISUAL IMPAIRMENT, WEIGHT FLUCTUATION, FATIGUE, SCIATICA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, FATIGUE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, SCIATICA, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: TRAILING COIL LEFT- 5, RIGHT- 5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM PATIENT¿S MEDICAL RECORD : BACK PAIN, ABDOMINAL PAIN . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2019: PFS AND MR RECEIVED- PREVIOUSLY REPORTED EVENT "INJURY TO HERSELF " UPDATED TO "HAIR LOSS", EVENTS- "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MIGRAINES / HEADACHES, URINARY TRACT INFECTION, VAGINAL INFECTION, BLADDER INFECTION, RASHES, SKIN CONDITION, DYSMENORRHEA (CRAMPING), DENTAL PROBLEM, VISION / EYE PROBLEMS, WEIGHT GAIN / LOSS, FATIGUE, BACK PAIN, SCIATIC NERVE PAIN, PELVIC PAIN, ABDOMINAL PAIN", REPORTER, LOT NUMBER, MEDICAL HISTORY, LAB DATA, CONCOMITANT DRUG, REPORTER ADDED. INCIDENT 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
    623333 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 851385- NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R ORAL CONTRACEPTIVE NOS.| ORAL CONTRACEPTIVE NOS.| ORAL CONTRACEPTIVE NOS