BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10138494 · Received June 10, 2020

    Report

    Report Number
    2951250-2020-08534
    Event Type
    Injury
    Date Received
    June 10, 2020
    Report Date
    April 27, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DEVICE MIGRATION') AND PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910509) 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 DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUN-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DEVICE MIGRATION') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910509) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAUTERINE DEVICE REMOVAL, DYSPAREUNIA, LEFT LOWER QUADRANT PAIN, WEIGHT GAIN, CONSTIPATION CHRONIC, PREGNANCY TEST NEGATIVE, MENSES IRREGULAR, SPOTTING VAGINAL, STRESS AND MENORRHAGIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF COILS TRAILING ON R: 2, NUMBER OF COILS TRAILING ON L: 7 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMATION TEST - YES. BILATERAL TUBAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-APR-2021: MR RECEIVED: REPORTER, MEDICAL HISTORY AND RCC 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.

    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 FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910509) 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY") AND DEVICE DISLOCATION ("DEVICE MIGRATION"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 09-JAN-2020: PIF RECEIVED. LOT NO RECEIVED. PELVIC PAIN, MIGRATION, BLEEDING AND PSYCHE INJURY EVENT ADDED. OUTCOME OF PAIN AND BLEEDING 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
    601585 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910509 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R