BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - HALO

    MDR report key: 9278339 · Received November 5, 2019

    Report

    Report Number
    3005099803-2019-05254
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 13, 2012
    Report Date
    November 5, 2019
    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 · 1

    REPORT SOURCE: OTHER: HEALTH CANADA ADVERSE INCIDENT REPORT REFERENCE NO 191413; SUBMITTED TO HC (HEALTH CANADA) BY THE PATIENT. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS IMPLANTED AND WILL NOT 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) 2012. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, THE PATIENT EXPERIENCED DREADFUL PAINS WHICH CAUSED HER PROBLEMS IN WALKING, RETURNING TO HER BED AND SEXUAL INTERCOURSE WAS NOT POSSIBLE. MOREOVER, THE PATIENT CAN NOT SIT FOR A LONG TIME, STAND UP AND HAD TROUBLE GETTING OUT OF THE CAR. SHE HAD A SMALL LUMP IN THE LEFT THIGH THAT WAS VERY SENSITIVE AND HER HIPS WERE JUST AS PAINFUL. THE PATIENT WOULD SCREAM WHEN TURNING AROUND AT NIGHT DUE TO PAIN. REPORTEDLY, THE PATIENT'S SCIATIC NERVE WAS STUCK AND FOUND HERSELF IN THE EMERGENCY ROOM LAST (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076545 OBTRYX SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505000 ML00000385 08714729718987

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R