BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8662088 · Received June 3, 2019

    Report

    Report Number
    2951250-2019-02377
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    November 1, 2013
    Report Date
    June 6, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834602-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2017, IBUPROFEN (MOTRIN), LORAZEPAM (ATIVAN) FROM (B)(6) 2017 TO (B)(6) 2018, MIDAZOLAM HYDROCHLORIDE (VERSED) FROM (B)(6) 2017 TO (B)(6) 2017 AND VITAMIN D NOS (VITAMIN D). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT PAIN"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEELING ABNORMAL ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: BRAIN FOG"), ENDOMETRIOSIS ("ENDMETRIOISIS") AND MOOD SWINGS ("MOOD SWING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND ARTHRALGIA HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEELING ABNORMAL, ANXIETY, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, ABDOMINAL PAIN AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE DEPRESSION AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2014: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUN-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)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834602) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2017, IBUPROFEN (MOTRIN), LORAZEPAM (ATIVAN) FROM (B)(6) 2017 TO (B)(6) 2018, MIDAZOLAM HYDROCHLORIDE (VERSED) FROM (B)(6) 2017 TO (B)(6) 2017 AND VITAMIN D NOS (VITAMIN D). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT PAIN"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEELING ABNORMAL ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: BRAIN FOG"), ENDOMETRIOSIS ("ENDOMETRIOSIS") AND MOOD SWINGS ("MOOD SWING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND ARTHRALGIA HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEELING ABNORMAL, ANXIETY, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, ABDOMINAL PAIN AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE DEPRESSION AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2014: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-MAY-2019: PFS RECEIVED:PRODUCT LOT NUMBER WAS ADDED. EVENT PELVIC PAIN, ABNORMAL VAGINAL BLEEDING, MENORRHAGIA, BRAIN FOG, ANXIETY, DEPRESSION, MIGRAINES, HEADACHES, DYSMENORRHEA, DYSPAREUNIA, ENDOMETRIOSIS, ABDOMINAL PAIN, BACK PAIN, JOINT PAIN, MOOD SWING WERE ADDED. PRODUCT STOP DATE ADDED. OUTCOME OF EVENT ABDOMINAL PAIN, BACK PAIN, JOINT PAIN WERE ADDED AS RECOVERED AND HEADACHE, DEPRESSION OUTCOME ADDED AS RECOVERING. EVENT INJURY NOS CHANGE TO PELVIC PAIN FEMALE. LAB DATA, REPORTERS, PATIENT DATE OF BIRTH, CONCOMITANT MEDICATION WERE ADDED. ON 22-MAY-2019: CODING CORRECTION (PROCESSED WITH FU FROM 22-MAY-2019). 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
    458204 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 834602-INVALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R ATIVAN| CYMBALTA| MOTRIN [IBUPROFEN]| VERSED| VITAMIN D [VITAMIN D NOS]| ATIVAN| CYMBALTA| MOTRIN [IBUPROFEN]| VERSED| VITAMIN D [VITAMIN D NOS]