BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINET AMERICAS BED

    MDR report key: 14014667 · Received April 4, 2022

    Report

    Report Number
    MW5108748
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 31, 2022
    Manufacturer
    LINET SPOL. S R.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DAMAGE TO LINET BED LOWER RAIL CASING. ON (B)(6) 2022 THE PATIENT EXPERIENCED A SUPERFICIAL SKIN TEAR AS A RESULT OF AN EXPOSED SHARP PLASTIC PIECE ON LINET BED RESULTING IN RIGHT CALF CELLULITIS WITH UNDERLYING VENOUS STASIS. THREE (3) DAYS POST INJURY PATIENT WAS AFEBRILE WITH NORMAL WBC'S BUT COMPROMISED AND AT SIGNIFICANT RISK FOR SEVERE INFECTION REQUIRING LOCAL WOUND CARE. ON (B)(6) 2022 PATIENT DEVELOPED INCREASING REDNESS RELATIVE TO SAID WOUND REQUIRING IV ANTIBIOTIC THERAPY THROUGH (B)(6) 2022 THEN ORAL ANTIBIOTIC THERAPY ADMINISTERED THROUGH (B)(6) 2022. DIALYSIS INITIATED DURING THIS HOSPITALIZATION. PATIENT DISCHARGED TO HOME (B)(6) 2022. PATIENT WITH PAST MEDICAL HISTORY OF DIABETES TYPE 2, CORONARY ARTERY DISEASE, OBESITY ADMITTED FOR ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE, HEAR FAILURE AND PLEURAL EFFUSION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339432 LINET AMERICAS BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL LINET SPOL. S R.O. MULTICARE LE 1MC5A650-197 20150075710

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention