BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVALON AIR TURN AND POSITION SYSTEM

    MDR report key: 4169572 · Received October 9, 2014

    Report

    Report Number
    1419181-2014-00003
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SAGE PRODUCTS LLC
    Product Code
    FMR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. INSTRUCTIONS FOR USE, PRODUCT DRAWING, AND MANUFACTURING SPECIFICATIONS WERE REVIEWED FOR THE DEVICE AND ALL ACCEPTANCE CRITERIA WERE MET. BASED UPON REVIEW OF THE AVAILABLE DOCUMENTATION, INCLUDING PRODUCT DRAWING, AND INSPECTION RECORD, THERE IS INSUFFICIENT EVIDENCE TO CONCLUDE THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO A PRODUCT DEFECT. PRODUCT NUMBER 700-050, LOT 800098 FUNCTIONED AS INTENDED AND NO FAILURES WERE IDENTIFIED.

    Description of Event or Problem · 1

    REPORT RECEIVED OF A PATIENT FALL IN A LONG TERM CARE FACILITY. THE FACILITY REPORTED THAT THE PREVALON AIR TURN AND POSITION SYSTEM WAS ON THE PATIENT'S BED AT THE TIME OF THE FALL. THE FACILITY REPORTED THAT THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE INCIDENT AS IT WAS AN "UNWITNESSED" FALL. HOWEVER, THE FACILITY DID NOT THINK THE "SAGE BLUE SHEET WAS THE CAUSE OF THE FALL." AFTER THE INCIDENT, PATIENT WAS EVALUATED BY PHYSICIANS ON (B)(67) 2014, A RIGHT HIP FRACTURE WAS DISCOVERED. ALTHOUGH REQUESTED, THE FACILITY HAS DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635438 PREVALON AIR TURN AND POSITION SYSTEM MANUAL PATIENT TRANSFER DEVICE FMR SAGE PRODUCTS LLC 700-050 800098

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other