BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYTE Y-MESH GRAFT

    MDR report key: 4101680 · Received August 28, 2014

    Report

    Report Number
    1018233-2014-00222
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BARD SHANNON LTD
    Product Code
    OTO
    PMA / PMN Number
    K101722
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED. NO SAMPLE WAS RETURNED FOR EVAL AND THE LOT NUMBER IS UNK. BASED ON THE INVESTIGATION FINDINGS, CURRENT MFG CONTROLS ARE CONSIDERED ADEQUATE AS TO DETECT AND SEGREGATE ANY NONCONFORMING UNIT. EVENT DESCRIBED COULD NOT BE CONFIRMED AS A MFG RELATED ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED FOR PELVIC ORGAN PROLAPSE ON (B)(6) 2012. SINCE IMPLANT DATE PT HAS EXPERIENCED URINARY RETENTION, VAGINAL PAIN, ABDOMINAL PAIN, PAIN WITH INTERCOURSE, LOW BACK PAIN, BLEEDING, CHRONIC INFLAMMATION AND A GENERAL FEELING OF FATIGUE. PT REPORTS HAVING SURGERY TO ATTEMPT REMOVAL (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526126 ALYTE Y-MESH GRAFT OTO BARD SHANNON LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ZANAFLEX