BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7001074 · Received November 3, 2017

    Report

    Report Number
    2951250-2017-06231
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    December 1, 2011
    Report Date
    August 8, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 /PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE FROM 2001 TO 2006. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN / PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA),"), HEADACHE ("HEADACHE"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ONE OR MORE SURGERIES TO REMOVE ESSURE (UNSPECIFIED)) AND SURGERY (ABLATION,). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, MIGRAINE, DYSMENORRHOEA AND DYSPAREUNIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 4 RIGHT 4.INTRAURERINE CAVITY WITHIN NORMAL LIMITS AND THE ABLATION WAS SUCCESSFUL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT :MENORRHAGIA, DYSMENORRHEA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-APR-2018: PFS + MR RECEIVED, REPORTER ADDED, DEMOGRAPHIC ADDED, LAB DATA ADDED,HISTORICAL DRUG ADDED, LOT NUMBER RECEIVED, EVENTS ADDED ARE AS FOLLOWS- VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, MIGRAINE, DYSMENORRHEA, DYSPAREUNIA,. INCIDENT. AT THE TIME OF REPORTING, 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.

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN /PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE FROM 2001 TO 2006. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN / PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA),"), HEADACHE ("HEADACHE"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ONE OR MORE SURGERIES TO REMOVE ESSURE (UNSPECIFIED)) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, MIGRAINE, DYSMENORRHOEA AND DYSPAREUNIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 4 RIGHT 4. INTRAUTERINE CAVITY WITHIN NORMAL LIMITS AND THE ABLATION WAS SUCCESSFUL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT :MENORRHAGIA, DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: AT THE TIME OF REPORTING, 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING ") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN ") AND VULVOVAGINAL PAIN ("VAGINAL PAIN "). THE PATIENT WAS TREATED WITH SURGERY (ONE OR MORE SURGERIES TO REMOVE ESSURE (UNSPECIFIED)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. INCIDENT: NO 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
    778955 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910512

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R DEPO PROVERA| DEPO PROVERA