BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 4071274 · Received September 4, 2014

    Report

    Report Number
    1213643-2014-00317
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 13, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, THE EXPLANTED DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS MDR INCLUDES ALL PT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PT'S SURGEON: IT WAS REPORTED BY THE PT'S SURGEON THAT HE REMOVED THE VENTRALEX PATCH DUE TO COMPLAINTS OF PAIN AND DISCOMFORT FROM THE PT. THE SURGEON STATED THAT THE PT BELIEVED THE MESH PATCH WAS THE CAUSE OF THE PAIN AND DISCOMFORT, HOWEVER, HE STATED THAT HE FELT IT WAS IN RELATION TO THE PT'S ANXIETIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539792 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA BU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention