BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMITTENT DVT CALF GARMENT

    MDR report key: 3021571 · Received March 15, 2013

    Report

    Report Number
    1417592-2013-00025
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED VIA A MEDWATCH REPORT THAT A PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE ULCER ON HIS LEFT LATERAL ANKLE FROM THE DEVICE TUBE WHERE IT MEETS THE SLEEVE. MULTIPLE PHONE CALLS AND EMAIL ATTEMPTS WERE MADE TO GATHER SPECIFIC DETAILS FROM THE FACILITY BUT THEY DID NOT RESPOND. WE DON NOT KNOW IF THE SLEEVE HAD BEEN CORRECTLY SIZED, APPLIED AND/OR POSITIONED ON THE PATIENT. IT IS NOT KNOWN HOW LONG THE DEVICE HAD BEEN IN PLACE OR HOW OFTEN SKIN INTEGRITY ASSESSMENTS WERE PERFORMED. THE DESCRIPTION OF THE PRESSURE ULCER WAS NOT REPORTED OR DETAILS PERTAINING TO ANY SUBSEQUENT TREATMENT. IF THE SLEEVE WAS NOT CORRECTLY PLACED ON THE PATIENT AND / OR IF THE PATIENT WAS LAYING ON THE EXIT TUBING, PRESSURE POINTS COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE ULCER ON HIS LEFT LATERAL ANKLE WHILE WEARING THE GARMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110883 INTERMITTENT DVT CALF GARMENT JOW MEDLINE INDUSTRIES, INC. 12100801

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R