BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOOR CUSHION, BEVELED GLOW

    MDR report key: 14605957 · Received June 6, 2022

    Report

    Report Number
    2182318-2022-00054
    Event Type
    Injury
    Date Received
    June 6, 2022
    Report Date
    May 10, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED SOLELY ON THE CUSTOMERS ALLEGATIONS THAT RESULTED IN A PATIENT FALL WITH SERIOUS INJURIES. THE DEVICE WAS REQUESTED TO BE RETURNED BUT WILL NOT BE RETURNED AS IT HAS BEEN RETURNED TO THEIR STOCK. THE PRODUCT LOT INFORMATION WAS NOT PROVIDED, THEREFORE THE RELEASE DOCUMENTATION COULD NOT BE REVIEWED. THE CUSTOMER CONFIRMED THERE WAS NO DEVICE MALFUNCTION AND THEY WERE NOT CONCERNED WITH THE INTEGRITY OF THE MAT. THE CUSTOMER IS CONCERNED OF THE PRODUCT WAS NOT BEING PROPERLY USED. MARK HENDERSON, A TERRITORY MANAGER FOR POSEY PRODUCTS, CONTACTED CUSTOMER AND RETRAINED ON PROPER USAGE OF PRODUCT WHILE PATIENT IS OUT OF THE ROOM AND WHILE IN USE. BASED ON THE INFORMATION PROVIDED BY THE POSEY TERRITORY MANAGER, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4). PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL A PATIENT FELL AND FRACTURED THEIR C1. THEY ADVISED THEY ARE NOT WORRIED ABOUT THE INTEGRITY OF THE MAT BUT WANT TO BE SURE THEY ARE USING THE MAT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319380 FLOOR CUSHION, BEVELED GLOW BED, AC-POWERED ADJUSTABLE HOSPITAL FNL TIDI PRODUCTS 6027R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown