BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10082822 · Received May 22, 2020

    Report

    Report Number
    2951250-2020-08105
    Event Type
    Injury
    Date Received
    May 22, 2020
    Report Date
    May 19, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINITIS, DYSPAREUNIA, FIBROMYALGIA AND OSTEOARTHRITIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), INJURY ("INJURY TO HERSELF"), BLADDER DISORDER ("BLADDER/URINARY PROBLEM"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEM"), DEPRESSION ("PSYCH INJURY") AND ANXIETY ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY + BI-S (BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, BLADDER DISORDER AND URINARY TRACT DISORDER HAD RESOLVED AND THE INJURY, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INJURY WITH ESSURE. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE CONFIRMATION TEST DONE ON (B)(6) 2012 PATIENT WAS TREATED FOR PAIN, BLEEDING AND BLADDER/URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: 1. BILATERAL ESSURE DEVICES IN THE FALLOPIAN TUBES ARE APPROPRIATELY POSITIONED. BOTH FALLOPIAN TUBES ARE OCCLUDED. THERE IS NO SPILL OF CONTRAST FROM THE FALLOPIAN TUBES INTO THE PELVIS. 2. THE UTERINE CAVITY IS NORMAL.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-APR-2021: REAL FU WAS RECEIVED AND THERE WAS NO SIGNIFICANT CHANGE IN THE MEDICAL CONTEXT OF CASE. REPORTER, LAB DATA AND MEDICAL HISTORY ADDED FROM MR. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINITIS, DYSPAREUNIA, FIBROMYALGIA AND OSTEOARTHRITIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), INJURY ("INJURY TO HERSELF"), BLADDER DISORDER ("BLADDER/URINARY PROBLEM"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEM"), DEPRESSION ("PSYCH INJURY") AND ANXIETY ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY + BI-S (BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, BLADDER DISORDER AND URINARY TRACT DISORDER HAD RESOLVED AND THE INJURY, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INJURY WITH ESSURE. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE CONFIRMATION TEST DONE ON (B)(6) 2012. PATIENT WAS TREATED FOR PAIN, BLEEDING AND BLADDER/URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: 1. BILATERAL ESSURE DEVICES IN THE FALLOPIAN TUBES ARE APPROPRIATELY POSITIONED. BOTH FALLOPIAN TUBES ARE OCCLUDED. THERE IS NO SPILL OF CONTRAST FROM THE FALLOPIAN TUBES INTO THE PELVIS. 2. THE UTERINE CAVITY IS NORMAL. LOT NUMBER: 940969; MANUFACTURING DATE: 2012/01; EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INJURY ("INJURY TO HERSELF"), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), BLADDER DISORDER ("BLADDER/ URINARY PROBLEM"), URINARY TRACT DISORDER ("BLADDER/ URINARY PROBLEM"), DEPRESSION ("PSYCH INJURY") AND ANXIETY ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY + BI-S (BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE INJURY, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, BLADDER DISORDER AND URINARY TRACT DISORDER HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INJURY WITH ESSURE. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE CONFIRMATION TEST DONE ON (B)(6) 2012 PATIENT WAS TREATED FOR PAIN, BLEEDING AND BLADDER/ URINARY PROBLEM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. CASE IS VALID. NEW EVENTS "PAIN, ABNORMAL BLEEDING, BLADDER/ URINARY PROBLEM AND PSYCH INJURY" WERE ADDED. ESSURE REMOVAL AND INSERTION DATES ADDED. LOT NUMBER 940969 WAS ADDED. WE RECEIVED A LOT NUMBER/ RETURNED SAMPLE/ SERIAL 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
    546137 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940969 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R