BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10406829 · Received August 14, 2020

    Report

    Report Number
    2951250-2020-13231
    Event Type
    Injury
    Date Received
    August 14, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 022369-NOT VALID,822369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ESSURE PERFORMED FOR UNDESIRED FERTILITY AND THERMACHOICE PERFORMED FOR MENORRHAGIA". THE PATIENT'S MEDICAL HISTORY INCLUDED MENORRHAGIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), URINARY TRACT DISORDER ("URINARY PROBLEMS"), UTERINE PAIN ("UTERINE PAIN") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, URINARY TRACT DISORDER, UTERINE PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HEADACHE, PELVIC PAIN, URINARY TRACT DISORDER AND UTERINE PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF PROXIMAL COILS: 2 ON LEFT CORNUA AND 2 ON RIGHT CORNUA. PATIENT TOLERATED PLACEMENT WITHOUT DIFFICULTY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE WAS DESCRIBED IN PATIENT MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR LOT NUMBER: 822369 MANUFACTURE DATE:2011-01 EXPIRATION DATE:2014-01. LOT NUMBER {022369} REPORTED IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. 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 PELVIC PAIN ('PAIN') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 022369-INV,822369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ESSURE PERFORMED FOR UNDESIRED FERTILITY AND THERMACHOICE PERFORMED FOR MENORRHAGIA". THE PATIENT'S MEDICAL HISTORY INCLUDED MENORRHAGIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), URINARY TRACT DISORDER ("URINARY PROBLEMS"), UTERINE PAIN ("UTERINE PAIN") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, URINARY TRACT DISORDER, UTERINE PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HEADACHE, PELVIC PAIN, URINARY TRACT DISORDER AND UTERINE PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF PROXIMAL COILS: 2 ON LEFT CORNUA AND 2 ON RIGHT CORNUA. PATIENT TOLERATED PLACEMENT WITHOUT DIFFICULTY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE WAS DESCRIBED IN PATIENT MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR. LOT NUMBER: 822369 MANUFACTURE DATE:2011-01 EXPIRATION DATE:2014-01. LOT NUMBER {022369} REPORTED IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2020: PIF RECEIVED: CASE HAS BECOME SERIOUS INCIDENT. NEW EVENTS WERE ADDED: UTERINE PAIN, HEADACHES. CLUSTER ID WERE ADDED AND REPORTER INFORMATION WERE UPDATED. 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
    874084 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 022369-NOT VALID,822369 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R