BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12161848 · Received July 13, 2021

    Report

    Report Number
    2951250-2021-02887
    Event Type
    Injury
    Date Received
    July 13, 2021
    Report Date
    July 19, 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 DEVICE DISLOCATION ('THE ESSURE COIL WAS SEEN PROTRUDING THROUGH THE STUMP OF THE TUBE THAT WAS LEFTATTACHED TO THE UTERUS, BUT WAS INTACT.') AND HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA') 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 PELVIC PAIN, PERINEAL PAIN, CHRONIC CERVICITIS, DYSMENORRHEA, PARITY 2, PREMENSTRUAL DYSPHORIC DISORDER, PAIN IN HIP, MOOD CHANGE, PARATUBAL CYST AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (ANCEF O), DIAZEPAM (VALIUM), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL), MECLOZINE HYDROCHLORIDE;PYRIDOXINE HYDROCHLORIDE (PNV) AND METRONIDAZOLE (FLAGYL 250). 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), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HEAVY MENSTRUAL BLEEDING AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA AND HEAVY MENSTRUAL BLEEDING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS TRAILING- LEFT 4 AND RIGHT 4 COIL UPON LAPAROSCOPY, THE UTERUS AND FALLOPIAN TUBES ARE NORMAL IN APPEARANCE. THE ESSURE COILS HAVE NOT PERFORATED THE FALLOPIAN TUBES. 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 19-JUL-2021: QUALITY SAFETY EVALUATION OF PTC 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 DEVICE DISLOCATION ('THE ESSURE COIL WAS SEEN PROTRUDING THROUGH THE STUMP OF THE TUBE THAT WAS LEFT ATTACHED TO THE UTERUS, BUT WAS INTACT.') AND HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA') 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 PELVIC PAIN, PERINEAL PAIN, CHRONIC CERVICITIS, DYSMENORRHEA, PARITY 2, PREMENSTRUAL DYSPHORIC DISORDER, PAIN IN HIP, MOOD CHANGE, PARATUBAL CYST AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (ANCEF O), DIAZEPAM (VALIUM), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL), MECLOZINE HYDROCHLORIDE;PYRIDOXINE HYDROCHLORIDE (PNV) AND METRONIDAZOLE (FLAGYL 250). 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), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HEAVY MENSTRUAL BLEEDING AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA AND HEAVY MENSTRUAL BLEEDING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS TRAILING- LEFT 4 AND RIGHT 4 COIL UPON LAPAROSCOPY, THE UTERUS AND FALLOPIAN TUBES ARE NORMAL IN APPEARANCE. THE ESSURE COILS HAVE NOT PERFORATED THE FALLOPIAN TUBES. 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 8-JUL-2021: MEDICAL RECORD RECEIVED : REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT MEDICATION, EVENT INJURY NOS REPLACE WITH THE ESSURE COIL WAS SEEN PROTRUDING THROUGH THE STUMP OF THE TUBE THAT WAS LEFT ATTACHED TO THE UTERUS, BUT WAS INTACT. EVENT ADDED:MENORRHAGIA,DYSMENORRHEA. CASE BECOME SERIOUS INCIDENT. 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
    1057444 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ANCEF O| ANCEF O| DOXYCYCLINE| DOXYCYCLINE| FLAGYL 250| FLAGYL 250| PNV| PNV| TORADOL| TORADOL| VALIUM| VALIUM