BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSEY BEVELED FLOOR CUSHION

    MDR report key: 16919564 · Received May 12, 2023

    Report

    Report Number
    2182318-2023-00037
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    January 6, 2023
    Report Date
    April 14, 2023
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    FNL
    UDI-DI
    10190676000439
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 THE PRODUCT IS SCHEDULED TO BE RETURNED BUT HAS NOT BEEN RECEIVED IN BY MANUFACTURER AT THE TIME OF THIS REPORT. TIDI WAS NOTIFIED BY GUST ROSENFELD LAW OFFICE OF A POTENTIAL CLAIM WITH A POSEY FLOOR CUSHION. THIS REPORT IS BASED SOLELY ON THE ALLEGATIONS THAT RESULTED IN A PATIENT FALL WITH SERIOUS INJURIES. AN ATTEMPT WAS MADE TO CONTACT THE USER FACILITY TO COLLECT INFORMATION SURROUNDING THE EVENT AND TO CONFIRM THE PRODUCT PART NUMBER. EMAIL COMMUNICATION WAS ALSO SENT TO PETER COLLINS, AN ATTORNEY AT GUST ROSENFELD LAW OFFICE, IN AN EFFORT TO GATHER INFORMATION SURROUNDING THE INCIDENT AND TO GET PRODUCT RETURNED FOR INVESTIGATION. PETER COLLINS, LAWYER INVESTIGATING THE CASE WAS ABLE TO CONFIRM THERE WAS NO DEVICE MALFUNCTION AND THAT THE PRODUCT WILL BE RETURNED TO TIDI PRODUCTS FOR INVESTIGATION. THE PRODUCT LOT INFORMATION WAS NOT PROVIDED, THEREFORE THE RELEASE DOCUMENTATION COULD NOT BE REVIEWED. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. INTENDED USE OF THE FLOOR CUSHIONS ARE TO REDUCE THE RISK OF INJURY DUE TO A PATIENT FALL FROM THE BED. THEY ARE INDICATED FOR PATIENTS WHO ARE AT HIGH RISK OF FALL-RELATED INJURIES FROM THE BED. WARNINGS STATE TO INFORM RESIDENTS AND STAFF TO TAKE CARE WHEN STEPPING ON OR OFF OF THE CUSHION TO AVOID TRIPPING. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. 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).

    Description of Event or Problem · 0

    TIDI RECEIVED A LETTER IN THE MAIL FROM GUST ROSENFELD LAW OFFICE INDICATING THEY RECEIVED A LETTER FROM ANOTHER LAWYER STATING THEIR CLIENT HAD SLIPPED ON A POSEY FALL MAT WHILE VISITING HER SON IN THE HOSPITAL. SHE FRACTURED HER WRIST DUE TO THE FALL. LETTER STATES: SHE CAME IN THE ROOM AND PLACED HER PURSE ON A CHAIR AND THEN TURNED HER BODY, DURING THE PROCESS OF TURNING THE FRONT OF HER FOOT CAUGHT AGAINST THE MAT PLACED ON THE SIDE OF HER SONS BED. SHE ALSO INDICATES LOWER BACK INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167677 POSEY BEVELED FLOOR CUSHION BED, AC-POWERED ADJUSTABLE HOSPITAL FNL TIDI PRODUCTS, LLC 6027 10190676000439

    Patients

    Seq Age Sex Outcome Treatment
    1 Female