BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 2050580 · Received March 15, 2011

    Report

    Report Number
    1313850-2011-00037
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: WELD.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY (B)(6) HOSPITAL THAT THE MANIFOLD ASSEMBLY THEY RECEIVED IS LEAKING ALONG THE WELD ON THE BACK SIDE OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT A/C HOSPITAL BED FNL GAYMAR INDUSTRIES, INC. 07305001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK