BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10394590 · Received August 12, 2020

    Report

    Report Number
    2951250-2020-13059
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    August 18, 2020
    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 MEDICAL DEVICE REMOVAL ('PARTIAL REMOVAL OF ESSURE DEVICE ON THE RIGHT SIDE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890, 12496680) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "TUBAL PATENCY ON THE". THE PATIENT'S MEDICAL HISTORY INCLUDED HIV POSITIVE, CHLAMYDIAL INFECTION AND UMBILICAL HERNIA REPAIR. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED PELVIC ADHESIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED COMPLICATION OF DEVICE REMOVAL ("ESSURE DEVICE WAS REMOVED PARTIALLY DUE TO THE SEVERE ADHESION AND SCARRING /PARTIAL REMOVAL OF ESSURE DEVICE ON THE RIGHT SIDE."). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION OF DEVICE REMOVAL AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONFIRMATION TEST DISCREPANCY : (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TUBE IT OCCLUDED AT THE CORNUA OR CONTRAST WITHIN THE TUBE BUT NOT ANY PORTION OF DISTAL AND OUTER COIL OF MICOINSERT: RIGHT CONTRAST IS SEEN PAST THE MICROINSERT OR CONTRAST IS SEEN IN PERITONEAL CAVITY: LEFT. LOT NUMBER:12496680 MANUFACTURE DATE:2011-07 EXPIRATION DATE:2014-04. LOT NUMBER:810890 MANUFACTURE DATE:2010-12 EXPIRATION DATE:2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('PARTIAL REMOVAL OF ESSURE DEVICE ON THE RIGHT SIDE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890, 12496680) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "TUBAL PATENCY ON THE". THE PATIENT'S MEDICAL HISTORY INCLUDED HIV POSITIVE, CHLAMYDIAL INFECTION AND UMBILICAL HERNIA REPAIR. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED PELVIC ADHESIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED COMPLICATION OF DEVICE REMOVAL ("ESSURE DEVICE WAS REMOVED PARTIALLY DUE TO THE SEVERE ADHESION AND SCARRING /PARTIAL REMOVAL OF ESSURE DEVICE ON THE RIGHT SIDE."). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION OF DEVICE REMOVAL AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONFIRMATION TEST DISCREPANCY: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: TUBE IT OCCLUDED AT THE CORNUA OR CONTRAST WITHIN THE TUBE BUT NOT ANY PORTION OF DISTAL AND OUTER COIL OF MICOINSERT: RIGHT CONTRAST IS SEEN PAST THE MICROINSERT OR CONTRAST IS SEEN IN PERITONEAL CAVITY: LEFT. 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
    861296 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 810890, 12496680 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R