BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8747619 · Received July 1, 2019

    Report

    Report Number
    2951250-2019-03152
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    September 1, 2011
    Report Date
    July 3, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') AND DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, VAGINAL PAIN, CRAMP IN LOWER ABDOMEN, FEVER, CHILLS, NAUSEA, VOMITING, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, HSV INFECTION, ANEMIA, HYPERLIPAEMIA, BLEEDING MENSTRUAL HEAVY, MUCOSAL THICKENING, MUCOSAL HYPERTROPHY, EAR RINGING, BLURRED VISION, POSTPARTUM DISORDER AND ELEVATED BP. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF COILS ON LEFT: 4, NUMBER OF COILS ON RIGHT: 2. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: HEADACHES, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') AND DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, VAGINAL PAIN, CRAMP IN LOWER ABDOMEN, FEVER, CHILLS, NAUSEA, VOMITING, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, HSV INFECTION, ANEMIA, HYPERLIPAEMIA, BLEEDING MENSTRUAL HEAVY, MUCOSAL THICKENING, MUCOSAL HYPERTROPHY, EAR RINGING, BLURRED VISION, POSTPARTUM DISORDER AND ELEVATED BP. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF COILS ON LEFT: 4, NUMBER OF COILS ON RIGHT: 2 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: HEADACHES, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH, MIGRAINES / HEADACHES, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN, LOWER BACK PAIN. DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT. REPORTER INFORMATION, LAB DATA, MEDICAL HISTORY, CONCOMITANT DRUG WERE 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 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
    543492 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822374 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R ACETAMINOPHEN.| ACETAMINOPHEN.| NSAIDS.| NSAIDS.| ACETAMINOPHEN| NSAIDS