BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMB HOLDER

    MDR report key: 20057300 · Received August 23, 2024

    Report

    Report Number
    2182318-2024-00105
    Event Type
    Injury
    Date Received
    August 23, 2024
    Report Date
    July 25, 2024
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    FMQ
    UDI-DI
    10190676005298
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. PRODUCT IS NOT AVAILABLE FOR RETURN OR EVALUATION. MANUFACTURING INVESTIGATION AND DOCUMENTATION REVIEW FOUND NO NON-CONFORMANCE'S OR ANOMALIES RELATED TO THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT, UNITS PASSED TESTING PRIOR TO RELEASE FOR DISTRIBUTION. HISTORICAL DATA FOUND COMPLAINTS FOR THE FOAM LIMB HOLDER PART 2510. OF THOSE RETURNED, EXCESSIVE FORCE AND/OR WEAR AND TEAR HAS CONTRIBUTED TO THE MALFUNCTION. ADDITIONALLY, USER ERROR RELATED TO MISAPPLICATION OF THE DEVICE PER THE INSTRUCTIONS FOR USE OR USE WITH INCORRECT PATIENT POPULATION WERE FOUND TO HAVE CONTRIBUTED TO SEVERAL SUCH COMPLAINTS. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU CONTRAINDICATIONS STATE DO NOT USE THIS DEVICE WITH SOMEONE WHO HAS CONTINUED HIGHLY AGGRESSIVE OR COMBATIVE BEHAVIOR, SELF-DESTRUCTIVE BEHAVIOR, OR DEEMED TO BE AN IMMEDIATE RISK TO OTHERS OR TO SELF. THE WARNINGS STATE ADDITIONAL OR DIFFERENT BODY OR LIMB RESTRAINTS MAY BE NEEDED (VISIT TIDIPRODUCTS.COM): 1. IF THE PATIENT PULLS VIOLENTLY AGAINST THE BED STRAPS, 2. TO REDUCE THE RISK OF THE PATIENT GETTING ACCESS TO THE LINE/WOUND/TUBE SITE. 3. TO PREVENT THE PATIENT FROM FLAILING OR BUCKING UP AND DOWN AND CAUSING SELF-INJURY. APPLICATION INSTRUCTION WARNINGS STATE: FAILURE TO COMPLETE EVERY STEP OF THE APPLICATION INSTRUCTIONS MAY RESULT IN PRODUCT FAILURE OR BREAKAGE. STEP 5 AND 6 STATE: CHECK TO MAKE SURE THE STRAP CANNOT SLIDE IN ANY DIRECTION OR LOOSEN IF THE PATIENT PULLS ON IT, OR IF THE BED IS ADJUSTED. ADJUST THE BED STRAP(S) TO ALLOW DESIRED FREEDOM OF MOVEMENT, WITHOUT COMPROMISING PATIENT OR CAREGIVER SAFETY. 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

    COMPLAINTS REPORTED PATIENT TORE THE TIES OFF THE RESTRAINT WITH BRUTE FORCE. THE PATIENT WAS ABLE TO SELF EXTUBATE. RESULTED IN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232561 LIMB HOLDER RESTRAINT, PROTECTIVE FMQ TIDI PRODUCTS LLC 2510 3264T019 10190676005298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown