BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056389 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08244
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    January 1, 2014
    Report Date
    January 2, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PELVIC INFECTION ("INFECTIONS/ INFECTION (OTHER) DESCRIBE: PELVIC") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 840019-INVALID) 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 ANY ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MICTURITION URGENCY, VULVOVAGINITIS, CANDIDA ALBICANS INFECTION, BREAST TENDERNESS, RECTAL PAIN, HEMORRHOIDS, VITAMIN D DEFICIENCY AND OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND GASTRIC ULCER. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("RECURRENT VAGINITIS"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), PROCTALGIA ("RECTAL PAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (BILATERAL SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), LEFT OVARIAN CYSTECTOMY AND BILATERAL SALPINGECTOMY BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC INFECTION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, PROCTALGIA, ABDOMINAL PAIN AND PERINEAL PAIN HAD RESOLVED AND THE ABDOMINAL DISTENSION, HYPERSENSITIVITY, WEIGHT INCREASED AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC INFECTION, PELVIC PAIN, PERINEAL PAIN, PROCTALGIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 145 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: WEIGHT GAIN, VAGINAL DISCHARGE, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-DEC-2018: UPDATE OF INFORMATION (BATCH IS INVALID). INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PELVIC INFECTION ("INFECTIONS/ INFECTION (OTHER) DESCRIBE: PELVIC") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840019) 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 ANY ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND GASTRIC ULCER. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("RECURRENT VAGINITIS"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), PROCTALGIA ("RECTAL PAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (BILATERAL SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND BILATERAL SALPINGECTOMY BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC INFECTION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, PROCTALGIA, ABDOMINAL PAIN AND PERINEAL PAIN HAD RESOLVED AND THE ABDOMINAL DISTENSION, HYPERSENSITIVITY, WEIGHT INCREASED AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC INFECTION, PELVIC PAIN, PERINEAL PAIN, PROCTALGIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 145 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED. REPORTER'S INFORMATION AND LOT NUMBER WAS ADDED. PREFERRED TERM OF EVENT INFECTIONS WAS UPDATED FROM INFECTION TO PELVIC INFECTION. EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), RECURRENT VAGINITIS, RECTAL PAIN, WEIGHT GAIN, VAGINAL DISCHARGE, ABDOMINAL PAIN, PERINEAL PAIN, SHE DID NOT UNDERGO ANY ESSURE CONFIRMATION TEST. OUTCOME OF EVENTS WERE UPDATED. CONCOMITANT DISEASE AND TREATMENT DRUG WAS ADDED. 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 ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, 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 DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC REACTIONS") AND INFECTION ("INFECTIONS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, HYPERSENSITIVITY AND INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INFECTION AND PELVIC 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
    836275 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 840019-INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R