BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPENCO MEDICAL CORP.

    MDR report key: 83103 · Received April 11, 1997

    Report

    Report Number
    1619779-1997-00001
    Event Type
    Injury
    Date Received
    April 11, 1997
    Date of Event
    April 7, 1995
    Report Date
    April 11, 1995
    Manufacturer
    SPENCO MEDICAL CORP.
    Product Code
    IMA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT USED CO'S HOT WRAP, WHICH IS A HOT COMPRESS TYPE DEVICE. SHE SAYS THAT SHE USED IT ACCORDING TO INSTRUCTIONS BUT THAT THE DEVICE STILL BURNED HER LEAVING A PERMANENT SCAR ON HER LEFT SHOULDER WHICH IS APPROX. 3 INCHES LONG AND WILL REQUIRE COSMETIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPENCO MEDICAL CORP. HOT COMPRESS IMA SPENCO MEDICAL CORP. * NA (CLASS I EXEMPT)

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention