BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPEP

    MDR report key: 6504626 · Received April 19, 2017

    Report

    Report Number
    3012970776-2017-00001
    Event Type
    Injury
    Date Received
    April 19, 2017
    Report Date
    January 23, 2017
    Manufacturer
    D R BURTON HEALTHCARE, LLC
    Product Code
    BWF
    PMA / PMN Number
    K991561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE # MW5067507 AND (B)(4). AS A RESPONSE TO THE MDR REPORT NUMBER MW5067507, D R BURTON HEALTHCARE, LLC PERFORMED AN INVESTIGATION INTO THE CLAIMS MADE AND PROVIDES THE FOLLOWING MANUFACTURER UPDATE: TO DATE D R BURTON HAS HAD NO DIRECT COMPLAINTS FROM ANY CUSTOMERS, THERE WAS NO HEALTHCARE PROFESSIONAL INFORMATION PROVIDED TO PURSUE THE BASIS OF THIS CLAIM, NO PRODUCT WAS RETURNED, AND POST MARKET SURVEILLANCE; WE CONTACTED 100% OF OUR CUSTOMERS AND 0% REPORTED ANY PROBLEMS WITH THIS REPORTED ISSUE OR ANY OTHER PRODUCT CONCERNS.

    Description of Event or Problem · 1

    REFERENCE #: MW5067507 AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287922 VPEP OPEP BWF D R BURTON HEALTHCARE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1