BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPENCO SILICONE CUSHION

    MDR report key: 393090 · Received May 3, 2002

    Report

    Report Number
    1619779-2002-00001
    Event Type
    Death
    Date Received
    May 3, 2002
    Date of Event
    March 21, 2002
    Manufacturer
    SPENCO MEDICAL CORP.
    Product Code
    IMP
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SPENCO MEDICAL CORPORATION CONDUCTED AN INVESTIGATION CONCERNING THIS INCIDENT. SPOKE WITH RN, THE COMPANY'S PRODUCT, (WHEELCHAIR PAD) COTTON POLYESTER ONE SIDE/URETHANE COATED NYLON WITH ONE SIDE/POLYESTER SILICONIZED FIBER INSIDE, HAD BEEN TIED TO THE RAIL OF THE BED TO PROTECT THE PT. SHE DID NOT BELIEVE THE CO'S PAD CAUSED THE PROBLEM AND WAS AWARE THAT WAS NOT THE INTENDED USE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REPORTER INFORMED SPENCO THERE WAS NO DEFECT WITH THE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPENCO SILICONE CUSHION * IMP SPENCO MEDICAL CORP. SILICORE FIBERS *

    Patients

    Seq Age Sex Outcome Treatment
    1