BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11811369 · Received May 12, 2021

    Report

    Report Number
    2951250-2021-02047
    Event Type
    Injury
    Date Received
    May 12, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PERINEAL PAIN AND PELVIC ADHESIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ADHESIONS ("ADHESIONS IN PELVIS") AND PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DILATION AND CURETTAGE, HYSTERECTOMY, DIAGNOSTIC LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ADHESIONS AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC ADHESIONS, PELVIC PAIN AND PERINEAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE FROM LEFT TUBE: COILED WIRE DEVICE CONSISTENT WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: PIF RECEIVED. REPORTER INFORMATION AND IMPLANT DATE WERE ADDED. FOLLOW UP AMENDED AS THE FRD (B)(6) 2021 REFLECTING WAS EARLIER THAN IRD (B)(6) 2021. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "REMOVED LEFT ESSURE WAS 25 CM LONG". ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ADHESIONS ("ADHESIONS IN PELVIS") AND PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DILATION AND CURETTAGE, HYSTERECTOMY, DIAGNOSTIC LAPAROSCOPY, REMOVAL OF LEFT ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ADHESIONS AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC ADHESIONS, PELVIC PAIN AND PERINEAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): LAPAROSCOPY - ON (B)(6) 2016: PROCEDURE WITH REMOVAL OF LEFT ESSURE AND SIGNIFICANT ADHESIONS IN PELVIS. BOTH OVARIES WERE NOTED AND APPEARED NORMAL; HOWEVER NEITHER TUBE WAS VISUALIZED. THE ESSURE IMPLANT WAS GRASPED ON THE LEFT AND REMOVED, SENT FOR PATHOLOGY. PATHOLOGY TEST - ON (B)(6) 2016: DIAGNOSIS: ESSURE FROM LEFT TUBE: COILED WIRE DEVICE CONSISTENT WITH ESSURE (GROSS ONLY). CLINICAL INFORMATION: PELVIC AND PERINEAL PAIN, RESIDUAL FOREIGN BODY IN SOFT TISSUE. SPECIMEN RECEIVED: ESSURE FROM LEFT TUBE. GROSS DESCRIPTION: ESSURE FROM LEFT TUBE: RECEIVED FRESH LABELED "ESSURE FROM LEFT TUBE" IS A 25.0 X 0.1 CM GRAY METALLIC COILED WIRE. SPECIMEN IS SUBMITTED FOR GROSS EXAMINATION ONLY. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUN-2021: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC). EVENT "REMOVED LEFT ESSURE WAS 25 CM LONG" ADDED. 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.

    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 INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PERINEAL PAIN AND PELVIC ADHESIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ADHESIONS ("ADHESIONS IN PELVIS") AND PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DILATION AND CURETTAGE, HYSTERECTOMY, DIAGNOSTIC LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ADHESIONS AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC ADHESIONS, PELVIC PAIN AND PERINEAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE FROM LEFT TUBE: COILED WIRE DEVICE CONSISTENT WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE 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
    708863 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R