BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8752219 · Received July 2, 2019

    Report

    Report Number
    2951250-2019-03195
    Event Type
    Injury
    Date Received
    July 2, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 TOOTH DISORDER ('DENTAL PROBLEMS') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 827945) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL ITCHING FROM 2009 TO 2011, NECK PAIN FROM 2008 TO 2010, POSTPARTUM DEPRESSION IN 2007 AND TONSILLECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: XANAX FROM 2007 TO 2011, LEXAPRO FROM 2010 TO 2011, TYLENOL-CODEIN IN 2010, ANAPROX IN 2009, LOESTRIN 24FE IN 2008 AND YAZ IN 2008. CONCURRENT CONDITIONS INCLUDED ASTHMA. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), IBUPROFEN, LORATADINE (LORCET) AND PROMETHAZINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / EXCESSIVE BLEEDING"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOOTH EXTRACTION AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED), SURGICAL REMOVAL OF COIL(S)). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, FATIGUE AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUL-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT WE RECEIVED A LOT NUMBER. 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 ('PELVIC PAIN') AND TOOTH DISORDER ('DENTAL PROBLEMS') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 827945) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL ITCHING FROM 2009 TO 2011, NECK PAIN FROM 2008 TO 2010, POSTPARTUM DEPRESSION IN 2007 AND TONSILLECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: XANAX FROM 2007 TO 2011, LEXAPRO FROM 2010 TO 2011, TYLENOL-CODEINE IN 2010, ANAPROX IN 2009, LOESTRIN 24FE IN 2008 AND YAZ IN 2008. CONCURRENT CONDITIONS INCLUDED ASTHMA. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), IBUPROFEN, LORATADINE (LORCET) AND PROMETHAZINE. ON (B)(6)-2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)-2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / EXCESSIVE BLEEDING"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOOTH EXTRACTION AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED), SURGICAL REMOVAL OF COIL(S)). ESSURE WAS REMOVED ON (B)(6)-2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, FATIGUE AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)-2011: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)-2019: PFS & MR RECEIVED. CASE BECOME INCIDENT. INJURY NOS REPLACED WITH NEW EVENTS. LOT NUMBER WAS ADDED. REPORTERS INFORMATION WAS ADDED. PATIENT'S DEMOGRAPHICS WAS ADDED. DATE OF INSERTION WAS UPDATED. DATE OF REMOVAL WAS ADDED. ADDED EVENT PELVIC PAIN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING),FATIGUE, BACK PAIN, TOOTH EXTRACTION. UPDATED ALL SYMPTOMS FROM UNKNOWN TO RECOVERED. MEDICAL HISTORY, HISTORICAL DRUGS, CONCOMITANT CONDITIONS, CONCOMITANT DRUG, 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
    545300 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 827945 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R IBUPROFEN| IBUPROFEN| LORCET [LORATADINE]| LORCET [LORATADINE]| PROMETHAZINE| PROMETHAZINE| VALIUM| VALIUM| IBUPROFEN| LORCET [LORATADINE]| PROMETHAZINE| VALIUM