BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7037209 · Received November 16, 2017

    Report

    Report Number
    2951250-2017-06650
    Event Type
    Injury
    Date Received
    November 16, 2017
    Report Date
    August 20, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: TIP OF ESSURE C,") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A73764/ 821578) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TYLENOL. CONCURRENT CONDITIONS INCLUDED HYPERLIPIDEMIA. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION ("PERFORATION,"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSPAREUNIA ("PAINFUL SEX,"), PAIN ("PAIN") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PERFORATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, DYSPAREUNIA, PAIN AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, PAIN, PELVIC PAIN, PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WAS NO EVIDENCE OF A "LOST" ESSURE ANYWHERE IN THE AB CAVITY OR WITHIN THE UTERUS. ON (B)(6) 2013, SHE IMPLANTED ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION, UNILATERAL OCCLUSION (R MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: REPORTERS ADDED AND PATIENT DEMOGRAPHIC ADDED. CONCOMITANT DISEASE AND LABORATORY DATA WERE ADDED. UPDATED SUSPECT DRUG INDICATION AND LOT NUMBER. ON (B)(6) 2013, SHE IMPLANTED ESSURE (PREVIOUSLY REPORTED AS (B)(6) 2013). ADDED EVENTS PAIN. ON (B)(6) 2015, SHE EXPLANTED ESSURE (PREVIOUSLY REPORTED AS (B)(6) 2015). UPDATED EVENT. 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 PERFORATION ("PERFORATION,"), DEVICE DISLOCATION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: TIP OF ESSURE C,") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A73764/ 821578) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TYLENOL. CONCURRENT CONDITIONS INCLUDED HYPERLIPIDEMIA. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSPAREUNIA ("PAINFUL SEX,"), PAIN ("PAIN") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT).ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, DYSPAREUNIA, PAIN AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, PAIN, PELVIC PAIN, PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WAS NO EVIDENCE OF A "LOST" ESSURE ANYWHERE IN THE AB CAVITY OR WITHIN THE UTERUS. ON (B)(6) 2013, SHE IMPLANTED ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION, UNILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION ("PERFORATION,"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSPAREUNIA ("PAINFUL SEX,") AND PAIN ("PAIN "). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PERFORATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, DYSPAREUNIA AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, PAIN, PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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
    818471 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A73764-INV, 821578-INV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R IBUPROFEN| IBUPROFEN