BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8990951 · Received September 11, 2019

    Report

    Report Number
    2951250-2019-06092
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    January 1, 2011
    Report Date
    September 12, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882185) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA AND MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND ORAL CONTRACEPTIVE. CONCURRENT CONDITIONS INCLUDED GLOSSODYNIA, SWOLLEN TONGUE, PAIN IN JAW, TINNITUS, PERINEAL PAIN, ENDOMETRIOSIS, UTERINE BLEEDING, VAGINAL BLEEDING, CERVICITIS AND UTERINE LEIOMYOMA. CONCOMITANT PRODUCTS INCLUDED CALCIUM LEVOMEFOLATE;DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (BEYAZ) SINCE 2011, ETHINYLESTRADIOL;NORGESTREL (NORGESTREL/ETHINYL ESTRADIOL), HYDROCODONE;PARACETAMOL (ACETAMINOPHEN;HYDROCODONE), IBUPROFEN, KETOROLAC, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), ONDANSETRON, PARACETAMOL (ACETAMINOPHEN), PROPRANOLOL, SERTRALINE HYDROCHLORIDE (SERTRALINE HCL) AND SUGAMMADEX SODIUM. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES / HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). . ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("RIGHT ABDOMEN/ CHRONIC ABDOMINAL PAIN"), COMPLICATION OF DEVICE INSERTION ("UNABLE TO PERFORM ESSURE BECAUSE UNABLE TO VISUALIZE RIGHT TUBAL OSTIA") AND ABDOMINAL PAIN UPPER ("PAIN IN STOMACH/ CHRONIC STOMACH PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: NOT SPECIFIED"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON(B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN AND ABDOMINAL PAIN UPPER HAD RESOLVED, THE MIGRAINE WAS RESOLVING AND THE COMPLICATION OF DEVICE INSERTION AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),PELVIC PAIN, ABDOMINAL PAIN, MIGRAINE TRAILING COILS: LEFT (B)(4). RIGHT:(B)(4). PATIENT RECEIVED TREATMENT FOR HORMONAL CHANGES,MIGRAINE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6)2012: ESSURE CONFIRMATION TEST (DYE TEST) -TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES IN PATIENT¿S MEDICAL RECORD; CONFIRMING- CRAMPING, COMPLICATION OF DEVICE INSERTION, PELVIC PAIN, MIGRAINE LOT NUMBER: 882185 MANUFACTURE DATE:2011-07 EXPIRATION DATE: 2014-07 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 ('PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882185) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA AND MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND ORAL CONTRACEPTIVE. CONCURRENT CONDITIONS INCLUDED GLOSSODYNIA, SWOLLEN TONGUE, PAIN IN JAW, TINNITUS, PERINEAL PAIN, ENDOMETRIOSIS, UTERINE BLEEDING, VAGINAL BLEEDING, CERVICITIS AND UTERINE LEIOMYOMA. CONCOMITANT PRODUCTS INCLUDED CALCIUM LEVOMEFOLATE; DROSPIRENONE; ETHINYLESTRADIOL BETADEX CLATHRATE (BEYAZ) SINCE 2011, ETHINYLESTRADIOL; NORGESTREL (NORGESTREL/ETHINYL ESTRADIOL), HYDROCODONE BITARTRATE; PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), IBUPROFEN, KETOROLAC, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), ONDANSETRON, PARACETAMOL (ACETAMINOPHEN), PROPRANOLOL, SERTRALINE HYDROCHLORIDE (SERTRALINE HCL) AND SUGAMMADEX SODIUM. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES / HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("RIGHT ABDOMEN/ CHRONIC ABDOMINAL PAIN"), COMPLICATION OF DEVICE INSERTION ("UNABLE TO PERFORM ESSURE BECAUSE UNABLE TO VISUALIZE RIGHT TUBAL OSTIA") AND ABDOMINAL PAIN UPPER ("PAIN IN STOMACH/ CHRONIC STOMACH PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: NOT SPECIFIED"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN AND ABDOMINAL PAIN UPPER HAD RESOLVED, THE MIGRAINE WAS RESOLVING AND THE COMPLICATION OF DEVICE INSERTION AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),PELVIC PAIN, ABDOMINAL PAIN, MIGRAINE TRAILING COILS: LEFT 5 RIGHT: 2. PATIENT RECEIVED TREATMENT FOR HORMONAL CHANGES,MIGRAINE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2012: ESSURE CONFIRMATION TEST (DYE TEST) -TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES IN PATIENT¿S MEDICAL RECORD; CONFIRMING- CRAMPING, COMPLICATION OF DEVICE INSERTION, PELVIC PAIN, MIGRAINE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PFS AND MR RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY" IS REPLACED WITH "PAIN", EVENTS- " MIGRAINES / HEADACHES, DYSMENORRHEA (CRAMPING), RIGHT ABDOMEN/ CHRONIC ABDOMINAL PAIN, UNABLE TO PERFORM ESSURE BECAUSE UNABLE TO VISUALIZE RIGHT TUBAL OSTIA, HORMONAL CHANGES DESCRIBE: NOT SPECIFIED", MEDICAL HISTORY, CONCOMITANT DRUGS, LOT NUMBER, REPORTERS, LAB DATA WERE 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784150 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882185 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN,HYDROCODONE| ACETAMINOPHEN,HYDROCODONE| BEYAZ| BEYAZ| DEPO PROVERA| DEPO PROVERA| IBUPROFEN| IBUPROFEN| KETOROLAC| KETOROLAC| NORGESTREL/ETHINYL ESTRADIOL| NORGESTREL/ETHINYL ESTRADIOL| ONDANSETRON| ONDANSETRON| PROPRANOLOL| PROPRANOLOL| SERTRALINE HCL| SERTRALINE HCL| SUGAMMADEX SODIUM| SUGAMMADEX SODIUM