BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10199699 · Received June 26, 2020

    Report

    Report Number
    2951250-2020-09641
    Event Type
    Injury
    Date Received
    June 26, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('MENSTRUAL CRAMPS BECAME MORE POWERFUL AFTER INSERTION OF ESSURE') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B72573) INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 4), PARITY 4 AND SHOULDER PAIN. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL METHOD: L BE 20 (INTERPRETED AS LAPAROSCOPY)). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA TO BE UNRELATED TO ESSURE. THE REPORTER COMMENTED: EVENTS NOT NECESSARILY RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. 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 PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('MENSTRUAL CRAMPS BECAME MORE POWERFUL AFTER INSERTION OF ESSURE') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B72573) INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 4), PARITY 4 AND SHOULDER PAIN. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL METHOD: L BE 20 (INTERPRETED AS LAPAROSCOPY)). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA TO BE UNRELATED TO ESSURE. THE REPORTER COMMENTED: EVENTS NOT NECESSARILY RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-NOV-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 PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('MENSTRUAL CRAMPS BECAME MORE POWERFUL AFTER INSERTION OF ESSURE') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B72573) INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 4), PARITY 4 AND SHOULDER PAIN. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL METHOD: L BE 20 (INTERPRETED AS LAPAROSCOPY)). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA TO BE UNRELATED TO ESSURE. THE REPORTER COMMENTED: EVENTS NOT NECESSARILY RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. 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
    662493 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B72573 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R