BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD TUBING

    MDR report key: 348536 · Received August 16, 2001

    Report

    Report Number
    1017072-2001-00003
    Event Type
    Malfunction
    Date Received
    August 16, 2001
    Date of Event
    July 27, 2001
    Report Date
    August 6, 2001
    Manufacturer
    KENDALL-SENECA
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO KENDALL THAT ON 2 OCCASIONS THE CENTER CHAMBER OF THE "SCD" SLEEVES HAD NOT DEFLATED. NO INFO WAS GIVEN OR VOLUNTEERED TO KENDALL IN REGARDS TO PERMANENT INJURY TO PTS AS A RESULT. ON FURTHER QUESTIONING KENDALL REALIZED THAT THE PROBLEM WAS WITH THE CONNECTING TUBING NOT WITH THE SLEEVES. TUBING HAS BEEN THE SUBJECT OF A RECALL BY KENDALL; USER FACILITY DID NOT RECEIVE RECALL INFO DUE TO THEIR CO CHANGE IN OWNERSHIP. PRODUCT CODES RECALLED WERE 5315/5320/5325/5328/5361/5378A. USER FACILITY HAS BEEN INFORMED OF RECALL, HAS WITHDRAWN AFFECTED TUBING FROM USE, AND HAS HAD NO FURTHER INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37523 SCD TUBING COMPRESSION SLEEVE TUBING JOW KENDALL-SENECA * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention