BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7821723 · Received August 28, 2018

    Report

    Report Number
    2951250-2018-03733
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    March 1, 2007
    Report Date
    August 30, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 402492-INV, 803200-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DIABETES AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEVORA FROM 2006 TO 2007, LOESTRIN FROM 2005 TO 2006 AND DEPOPROVERA FROM 1996 TO 2000. CONCURRENT CONDITIONS INCLUDED IRREGULAR MENSTRUATION. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2007, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2007, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION ON (B)(6) 2009). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ESSURE DEVICE PLACED WITH DIFFERENT 6-7 COILS RIGHT AND COILS IN LEFT. PATIENT TOLERATES PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA. LOT NUMBER 402492 AND 803200 REPORTED IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    "NTANEOUS" CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 402492-INV, 803200-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DIABETES AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEVORA FROM 2006 TO 2007, LOESTRIN FROM 2005 TO 2006 AND DEPOPROVERA FROM 1996 TO 2000. CONCURRENT CONDITIONS INCLUDED IRREGULAR MENSTRUATION. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2007, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2007, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (ABLATION ON (B)(6) 2009). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ESSURE DEVICE PLACED WITH DIFFERENT 6-7 COILS RIGHT AND COILS IN LEFT. PATIENT TOLERATES PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS INVALID). INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665342 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 402492-INV, 803200-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R