BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11694824 · Received April 20, 2021

    Report

    Report Number
    2951250-2021-01236
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    June 1, 2011
    Report Date
    April 22, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 838567) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTI, DYSURIA, FEMALE CONDOM, MENSTRUATION IRREGULAR, CRAMP IN LOWER ABDOMEN, BACK MUSCLE SPASMS AND BACK PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IBUPROFEN AND NEEVO DHA. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ), HYDROCORTISONE (CORTIZONE), NSAIDS, ORAL CONTRACEPTIVE NOS AND PARACETAMOL (ACETAMINOPHEN). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON 29-JUN-2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC REACTION"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HYPERSENSITIVITY, DEPRESSION, ANXIETY AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, HYPERSENSITIVITY, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT TREATMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE. ON (B)(6) 2011: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DATE DISCREPANCY NOTED IN ESSURE INSERTION DATE - (B)(6) 2011. DISCREPANCY NOTED AS PER PSF: DATE OF INSERTION OF ESSURE DEVICE: (B)(6) 2011. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-APR-2021: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 ('SEVERE PELVIC PAIN/ PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 838567) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTI, DYSURIA, FEMALE CONDOM, MENSTRUATION IRREGULAR, CRAMP IN LOWER ABDOMEN, BACK MUSCLE SPASMS AND BACK PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IBUPROFEN AND NEEVO DHA. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ), HYDROCORTISONE (CORTIZONE), NSAIDS, ORAL CONTRACEPTIVE NOS AND PARACETAMOL (ACETAMINOPHEN). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC REACTION"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HYPERSENSITIVITY, DEPRESSION, ANXIETY AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, HYPERSENSITIVITY, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT TREATMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE. ON (B)(6) 2011: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DATE DISCREPANCY NOTED IN ESSURE INSERTION DATE - (B)(6) 2011. DISCREPANCY NOTED AS PER PSF: DATE OF INSERTION OF ESSURE DEVICE: (B)(6) 2011 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-APR-2021: MR RECEIVED: REPORTER AND MEDICAL HISTORY 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594075 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 838567 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other ACETAMINOPHEN| ACETAMINOPHEN| CORTIZONE [HYDROCORTISONE]| CORTIZONE [HYDROCORTISONE]| NSAIDS| NSAIDS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| YAZ| YAZ