BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055976 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07751
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    May 1, 2012
    Report Date
    December 26, 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), HELICOBACTER INFECTION ("H. PYLORI INFECTION") AND HAEMATURIA ("MICROSCOPIC HEMATURIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862114) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, CYST OF OVARY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE FROM (B)(6) TO (B)(6) AND VITAMIN D NOS (VITAMIN D). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HELICOBACTER INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HAEMATURIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN LOWER ("RLQ PAIN"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("LEGS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY ,BILATERAL SALPINGECTOMY ,LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING, THE HELICOBACTER INFECTION, HAEMATURIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE VAGINAL DISCHARGE AND PAIN IN EXTREMITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSPAREUNIA, HAEMATURIA, HELICOBACTER INFECTION, PAIN IN EXTREMITY, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 LEFT TRAILING COILS AND4 TRAILING COILS ON THE RIGHT. TELEPHONE ENCOUNTER: PATIENT CALLS WITH INTERPRETER WITH RIGHT LEFT QUADRANT PELVIC PAIN SINCE MAY STATING THAT SHE CAN "FEEL THE COIL ON THAT SIDE MOVING AROUND". PATIENT ADVISED THAT ESSURE WOULD NOT BE LIKELY CULPRIT OF SYMPTOMS. ADVISED TO FOLLOW UP WITH PCP FIRST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-DEC-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PATIENT RELEVANT HISTORY ADDED. INDICATION (PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES) ADDED. LOT NUMBER (862114) ADDED. CONCOMITANT MEDICATIONS ADDED. EVENT ONSET DATES ADDED . EVENT OUTCOMES UPDATED. NEW EVENTS H. PYLORI INFECTION, MICROSCOPIC HEMATURIA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, RLQ PAIN AND LEGS PAIN ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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"), HELICOBACTER INFECTION ("H. PYLORI INFECTION") AND HAEMATURIA ("MICROSCOPIC HEMATURIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862114-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, CYST OF OVARY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE FROM 2012 TO 2016 AND VITAMIN D NOS (VITAMIN D). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HELICOBACTER INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HAEMATURIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN LOWER ("RLQ PAIN"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("LEGS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY ,BILATERAL SALPINGECTOMY ,LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING, THE HELICOBACTER INFECTION, HAEMATURIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE VAGINAL DISCHARGE AND PAIN IN EXTREMITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSPAREUNIA, HAEMATURIA, HELICOBACTER INFECTION, PAIN IN EXTREMITY, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 LEFT TRAILING COILS AND4 TRAILING COILS ON THE RIGHT. TELEPHONE ENCOUNTER: PATIENT CALLS WITH INTERPRETER WITH RIGHT LEFT QUADRANT PELVIC PAIN SINCE MAY STATING THAT SHE CAN "FEEL THE COIL ON THAT SIDE MOVING AROUND". PATIENT ADVISED THAT ESSURE WOULD NOT BE LIKELY CULPRIT OF SYMPTOMS. ADVISED TO FOLLOW UP WITH PCP FIRST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). 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 OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED 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
    835681 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 862114-INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R HYDROCODONE.| HYDROCODONE.| VITAMIN D [VITAMIN D NOS].| VITAMIN D [VITAMIN D NOS].