BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - HALO

    MDR report key: 9266704 · Received November 1, 2019

    Report

    Report Number
    3005099803-2019-05268
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    January 1, 2018
    Report Date
    July 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718987
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS F10 AND H6: PATIENT CODES E2330 AND E1309 CAPTURE THE REPORTABLE EVENTS OF CHRONIC PAIN AND URINARY RETENTION. IMPACT CODE F1202 CAPTURES THE REPORTABLE EVENT OF PATIENT'S INABILITY TO DO HER JOB. BLOCK G3: OTHER: HC ADVERSE INCIDENT REPORT REFERENCE NO (B)(4); SUBMITTED TO HC (HEALTH CANADA) BY THE PATIENT. BLOCK H6: CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - HALO WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT STARTED TO EXPERIENCE STOMACHACHE, SORE ON HER LOWER BACK, ON HER BOTH LEGS (BUT THE LEFT SIDE IS REPORTEDLY MORE SORE), AND IN HER GROIN THAT REPORTEDLY PULLS IN FROM HER VAGINA. DUE TO TOO MUCH PAIN, SHE CANNOT GET A COMFORTABLE POSITION TO SLEEP AND HARDLY SLEEPS AT NIGHT. SHE IS UNABLE TO DO HER JOB OFTEN AND IS NO LONGER ABLE TO LIFT A GROCERY BAG. FURTHERMORE, THERE IS BLOOD QUITE OFTEN. SHE ALSO RUNS TO THE BATHROOM TO URINATE AS HER URINE FLOWS UNCONTROLLABLY. WHEN SHE WALKS HER DOGS FOR ABOUT FIFTEEN MINUTES, SHE CANNOT HOLD HER DESIRE AND URINATES IN HER PANTS. SUBSEQUENTLY, SHE HAS TO WEAR A TOWEL AT ALL TIMES. *ADDITIONAL INFORMATION RECEIVED ON JUNE 24, 2021 VIA HC INCIDENT #(B)(4): ON (B)(6) 2018, THE PATIENT BEGAN TO EXPERIENCE CHRONIC PAIN IN HER PELVIC AREA, HIPS, URETHRA, LOWER ABDOMEN, LOWER BACK AND LABIA MAJORA, LEFT GROIN AND LEFT LEG. FURTHERMORE, SHE EXPERIENCED URINARY RETENTION, DYSPAREUNIA, EXTREME TIREDNESS, SWOLLEN LEFT GROIN GLANDS AND OCCASIONAL PAIN IN URINATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE: ALTHOUGH THE MOST RECENT MANUFACTURING SITE FOR OBTRYX IS BOSTON SCIENTIFIC IN SPENCER IN, THE REPORTED LOT INVOLVED IN THIS COMPLAINT WAS MANUFACTURED BY: (B)(4). REPORT SOURCE: OTHER: HC ADVERSE INCIDENT REPORT REFERENCE NO 189783; SUBMITTED TO HC (HEALTH CANADA) BY THE PATIENT. THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - HALO WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT STARTED TO EXPERIENCE STOMACHACHE, SORE ON HER LOWER BACK, ON HER BOTH LEGS (BUT THE LEFT SIDE IS REPORTEDLY MORE SORE), AND IN HER GROIN THAT REPORTEDLY PULLS IN FROM HER VAGINA. DUE TO TOO MUCH PAIN, SHE CANNOT GET A COMFORTABLE POSITION TO SLEEP AND HARDLY SLEEPS AT NIGHT. SHE IS UNABLE TO DO HER JOB OFTEN AND IS NO LONGER ABLE TO LIFT A GROCERY BAG. FURTHERMORE, THERE IS BLOOD QUITE OFTEN. SHE ALSO RUNS TO THE BATHROOM TO URINATE AS HER URINE FLOWS UNCONTROLLABLY. WHEN SHE WALKS HER DOGS FOR ABOUT FIFTEEN MINUTES, SHE CANNOT HOLD HER DESIRE AND URINATES IN HER PANTS. SUBSEQUENTLY, SHE HAS TO WEAR A TOWEL AT ALL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059687 OBTRYX SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505000 0000045391 08714729718987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other