BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONOVA-O2

    MDR report key: 23758758 · Received December 9, 2025

    Report

    Report Number
    3016947689-2025-00001
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 9, 2025
    Manufacturer
    TURN MEDICAL, LLC
    Product Code
    IKZ
    UDI-DI
    00860006962203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION, THE SERIAL NUMBER OF THE DEVICE ASSOCIATED WITH THE ALLEGED INJURY COULD NOT BE IDENTIFIED. MULTIPLE ATTEMPTS TO OBTAIN THE SERIAL NUMBER FROM THE HOSPITAL WERE ATTEMPTED WITHOUT SUCCESS. ALTHOUGH THE SPECIFIC SERIAL NUMBER REMAINS UNKNOWN, THE DEVICE WAS DETERMINED TO HAVE BEEN MANUFACTURED IN EITHER 2021 OR 2022. TURN MEDICAL CURRENTLY UTILIZES A THIRD-PARTY AFFILIATE, NEW SOURCE MEDICAL (NSM), FOR DEVICE SERVICING. THE DEVICE IS REUSABLE, AND AFTER EACH USE IT IS RETURNED TO NSM FOR CLEANING, DISINFECTION, AND QUALITY CONTROL (QC). A REVIEW OF ALL QC REPORTS FROM (B)(6) 2025 SHOWED NO DEVICE MALFUNCTIONS, AND ALL UNITS PASSED QC FOR SUBSEQUENT USE. TURN MEDICAL CONFIRMED THAT THE IFU PROVIDES APPROPRIATE INSTRUCTION FOR OPENING AND CLOSING THE PRONE PANELS. THIS COMPLAINT WILL BE CLOSED UNLESS ADDITIONAL INFORMATION IS PROVIDED TO THE COMPANY.

    Description of Event or Problem · 0

    TURN MEDICAL IS SUBMITTING THIS REPORT REGARDING AN ALLEGED INJURY ASSOCIATED WITH THE USE OF THE PRONOVA-O2 THERAPY SYSTEM. ON (B)(6) 2025, DURING A ROUTINE CALL WITH FACILITY MANAGEMENT, IT WAS DISCLOSED THAT THE INCIDENT HAD OCCURRED ON (B)(6) 2025. ACCORDING TO THE REPORTING NURSE MANAGER, THE EMPLOYEE WAS ASSISTING IN POSITIONING A PATIENT INTO SUPINATION WHEN THE HATCH AT THE UPPER END OF THE DEVICE UNEXPECTEDLY SPRANG BACK, STRIKING THE EMPLOYEE'S RIGHT WRIST AND RESULTING IN A SPRAIN. THE EMPLOYEE WAS SUBSEQUENTLY PLACED ON WORKERS' COMPENSATION AND REFERRED TO OCCUPATIONAL MEDICINE. AS OF (B)(6) 2025, THE NURSE MANAGER REPORTED THAT THE EMPLOYEE IS "OK" AND CURRENTLY WORKING UNDER LIGHT DUTY RESTRICTIONS. AN INVESTIGATION INTO THE INCIDENT DID NOT IDENTIFY ANY CONTRIBUTING FACTORS, NOR WAS ANY DEFICIENCY IN THE TURN MEDICAL DEVICE. TURN MEDICAL CONFIRMED THAT THE IFU PROVIDES APPROPRIATE INSTRUCTION FOR OPENING AND CLOSING THE PRONE PANELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554421 PRONOVA-O2 BED, PATIENT ROTATION, POWERED IKZ TURN MEDICAL, LLC 00860006962203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention