BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PACER PROJECT-MESH VENTRALEX

    MDR report key: 5147883 · Received October 8, 2015

    Report

    Report Number
    MW5056929
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 9, 2015
    Manufacturer
    DAVOL, A BARD COMPANY
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD VENTRAL HERNIORRHAPHY WITH BARD MESH REPAIR- (B)(6) 2015. RETURNED FOR POST OP VISIT (B)(6) 2015 AND PHYSICAL EXAM REVEALED POST-OP RECURRENT VENTRAL HERNIA AT INCISION SITE. RETURNED (B)(6) 2015 FOR REPAIR OF RECURRENT VENTRAL HERNIA. FINDINGS REVEAL NON-ADHERENT BARD MESH TO THE FASCIA ON 1 SIDE OF THE REPAIR. AFTER TAKING DOWN, THE MESH WAS REMOVED AND WAS COVERED WITH MESH UNDERLAY OF STRATUS MESH. THE MESH SAT NICELY WITHOUT ANY TENSION. PT WAS CLOSED AND EXTUBATED AND TAKEN TO RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669089 BARD PACER PROJECT-MESH VENTRALEX ABDOMINAL MESH FTL DAVOL, A BARD COMPANY 5950007 HUZD0180

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization