BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPSYLON Y MESH KIT

    MDR report key: 12929389 · Received December 3, 2021

    Report

    Report Number
    3005099803-2021-06850
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    February 15, 2016
    Report Date
    December 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OHD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ID: (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; 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.

    Additional Manufacturer Narrative · 0

    PATIENT ID: (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; 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 A UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2014. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; PELVIC PAIN; GROIN PAIN; THIGH PAIN; DIFFICULTIES WITH BOWEL MOTIONS; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE; AGGRAVATED INCONTINENCE; DAMAGE . NONSURGICAL TREATMENTS: ON (B)(6) 2016 THE PATIENT COMMENCED PAIN MEDICATION: PARACETAMOL CODEINE TABLETS FOR THE TREATMENT OF: FOR ON GOING PAIN. TREATMENT DURATION: STILL ON GOING. THE PATIENT WAS TREATED WITH PSYCHOLOGICAL MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2014. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; PELVIC PAIN; GROIN PAIN; THIGH PAIN; DIFFICULTIES WITH BOWEL MOTIONS; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE; AGGRAVATED INCONTINENCE; DAMAGE . NONSURGICAL TREATMENTS: ON (B)(6) 2016 THE PATIENT COMMENCED PAIN MEDICATION: PARACETAMOL CODEINE TABLETS FOR THE TREATMENT OF: FOR ON GOING PAIN. TREATMENT DURATION: STILL ON GOING. THE PATIENT WAS TREATED WITH PSYCHOLOGICAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826102 UPSYLON Y MESH KIT GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES OHD BOSTON SCIENTIFIC CORPORATION 72912

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention