BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10307388 · Received July 22, 2020

    Report

    Report Number
    2951250-2020-11981
    Event Type
    Injury
    Date Received
    July 22, 2020
    Report Date
    August 3, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('RIGHT INSERT IS BROKE AND PART OF IT IS IN THE ABDOMINAL CAVITY'), ECTOPIC PREGNANCY ('ECTOPIC PREGNANCY'), PERFORATION ('PERFORATION') AND DEVICE DISLOCATION ('RIGHT INSERT IS BROKE AND PART OF IT IS IN THE ABDOMINAL CAVITY') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED DISABLED CHILD. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("BLED FOR THREE MONTHS STRAIGHT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("PAIN SITTING") AND INFECTION ("INFECTION W/IV ANTIBIOTICS"), WAS FOUND TO HAVE AN ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ABDOMINAL PAIN ("PAIN ON HER RIGHT SIDE"), DYSPAREUNIA ("PAIN HAVING INTERCOURSE") AND DYSURIA ("PAIN URINATING"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2013. IN (B)(6) 2012, THE GENITAL HAEMORRHAGE HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, ECTOPIC PREGNANCY, PERFORATION, PAIN AND INFECTION OUTCOME WAS UNKNOWN, THE DEVICE DISLOCATION HAD NOT RESOLVED, THE ABDOMINAL PAIN HAD NOT RESOLVED AND THE DYSPAREUNIA AND DYSURIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSPAREUNIA, DYSURIA, ECTOPIC PREGNANCY, GENITAL HAEMORRHAGE, INFECTION, PAIN AND PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: TUBAL OCCLUSION IN THE LEFT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2020: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE BREAKAGE ('RIGHT INSERT IS BROKE AND PART OF IT IS IN THE ABDOMINAL CAVITY'), ECTOPIC PREGNANCY ('ECTOPIC PREGNANCY'), PERFORATION ('PERFORATION') AND DEVICE DISLOCATION ('RIGHT INSERT IS BROKE AND PART OF IT IS IN THE ABDOMINAL CAVITY') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED DISABLED CHILD. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("BLED FOR THREE MONTHS STRAIGHT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("PAIN SITTING") AND INFECTION ("INFECTION W/IV ANTIBIOTICS"), WAS FOUND TO HAVE AN ECTOPIC PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED ABDOMINAL PAIN ("PAIN ON HER RIGHT SIDE"), DYSPAREUNIA ("PAIN HAVING INTERCOURSE") AND DYSURIA ("PAIN URINATING"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2013. IN (B)(6) 2012, THE GENITAL HAEMORRHAGE HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, ECTOPIC PREGNANCY, PERFORATION, PAIN AND INFECTION OUTCOME WAS UNKNOWN, THE DEVICE DISLOCATION HAD NOT RESOLVED, THE ABDOMINAL PAIN HAD NOT RESOLVED AND THE DYSPAREUNIA AND DYSURIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSPAREUNIA, DYSURIA, ECTOPIC PREGNANCY, GENITAL HAEMORRHAGE, INFECTION, PAIN AND PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: TUBAL OCCLUSION IN THE LEFT.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PIF RECEIVED. NEW EVENTS INFECTION AND UTERINE PERFORATION WERE ADDED. ECTOPIC PREGNANCY 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
    772299 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 880433 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other| R