BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9675550 · Received February 6, 2020

    Report

    Report Number
    2951250-2020-00939
    Event Type
    Injury
    Date Received
    February 6, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND HYSTERECTOMY ('HYSTERECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. 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) AND UNDERWENT HYSTERECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY, BILATERAL ESSURE DEVICES REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYSTERECTOMY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SOUGHT TREATMENT FOR HER SYMPTOMS, BUT WAS UNABLE TO RESOLVE THEM. RIGHT COILS: 5. LEFT COILS:2. TOTAL LAPAROSCOPIC HYSTERECTOMY DONE ON (B)(6) 2014. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2020: MR RECEIVED. REPORTER'S INFORMATION ADDED. LOT NO. WERE ADDED. RCC WERE ADDED. EVENT MEDICAL DEVICE REMOVAL UPDATED TO PELVIC PAIN. NEW EVENT ADDED: HYSTERECTOMY. 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 LAWYER, AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND HYSTERECTOMY ('HYSTERECTOMY'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109), INSERTED FOR FEMALE STERILISATION. 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) AND UNDERWENT HYSTERECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY, BILATERAL ESSURE DEVICES REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYSTERECTOMY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SOUGHT TREATMENT FOR HER SYMPTOMS, BUT WAS UNABLE TO RESOLVE THEM. RIGHT COILS: 5; LEFT COILS: 2. TOTAL LAPAROSCOPIC HYSTERECTOMY DONE ON (B)(6) 2014. LOT NUMBER#: 952109, MANUFACTURING DATE: 2012-02, EXPIRATION DATE: 2015-02. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2020, QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 MEDICAL DEVICE REMOVAL ((B)(6) AND HAD A COMPLETE HYSTERECTOMY YESTERDAY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SOUGHT TREATMENT FOR HER SYMPTOMS, BUT WAS UNABLE TO RESOLVE THEM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. EVENT : INJURY NOS WAS REPLACED WITH MEDICAL DEVICE REMOVAL. CASE UPGRADED TO SERIOUS INCIDENT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138084 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952109 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R