BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - SURGIPRO¿

    MDR report key: 8838661 · Received July 29, 2019

    Report

    Report Number
    1219930-2019-04481
    Event Type
    Injury
    Date Received
    July 29, 2019
    Report Date
    July 29, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FTL
    UDI-DI
    10884521101371
    PMA / PMN Number
    K915526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 0110151 BARD DULEX MESH, LOT# BRSH6220, EXP: 08/2013; 174006(LOT#:P6D241). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF SEVERE ANTERIOR AND CERVICAL CUFF PROLAPSE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. THE DEVICE HAD BEEN USED WITH 0110151 BARD DULEX MESH, LOT# BRSH6220, EXP 08/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630107 MESH - SURGIPRO¿ MESH, SURGICAL, POLYMERIC FTL COVIDIEN LP LLC NORTH HAVEN SPM-35-W A7A592 10884521101371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other