BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/U240 9153653564

    MDR report key: 9866206 · Received March 23, 2020

    Report

    Report Number
    9616091-2020-00014
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 25, 2020
    Manufacturer
    INVAMEX MANUFACTURING
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TRSX5 MANUAL WHEELCHAIR WAS RETURNED TO INVACARE WHERE IT RECEIVED AN EXPANDED EVALUATION THAT WAS COMPLETED ON 05/29/2020. UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS ¿AS RECEIVED¿ CONDITION, THE COMPLAINT WAS CONFIRMED. THROUGH VISUAL INSPECTION OF THE LEFT WHEEL LOCK, IT WAS DETERMINED THAT TWO OF THE NYLON WASHERS WERE TORN/CRACKED. THIS DAMAGE CAUSED THE LEFT WHEEL LOCK HANDLE TO BECOME LOOSE AND THE LEFT WHEEL LOCK SHOE TO NOT FULLY ENGAGE TO PREVENT ROTATION OF THE DRIVE WHEEL. THE ISSUE IS CONSISTENT WITH THE CONSUMER IS OVER TIGHTENING THE BOLT CAUSING STRESS, WEAR AND TEAR ON THE WASHER. THE USER MANUAL STATES PART NO. 1110550 REV J, PAGE 29: INSPECT/ADJUST WEEKLY ENSURE THAT THE WHEEL LOCKS PREVENT THE WHEELCHAIR FROM MOVING WHEN ENGAGED.

    Description of Event or Problem · 0

    THE MOTHER REPORTED THAT HER DAUGHTER WAS IN THE TRSX58FBP WHEELCHAIR CLEANING THEIR ENTERTAINMENT CENTER. SHE BENT OVER TO PICK SOMETHING UP, AND ALLEGEDLY THE WHEEL LOCKS DID NOT HOLD. THE CHAIR TIPPED FORWARD, CAUSING HER TO FALL OUT. THE END-USER SUFFERED A FRACTURED RIGHT SHOULDER WHICH IS BEING TREATED WITH A BRACE.

    Additional Manufacturer Narrative · 1

    THE WHEELCHAIR HAS BEEN RETURNED TO INVACARE, HOWEVER, AN INSPECTION HAS NOT BEEN COMPLETED AT THE TIME OF THIS FILING. THE REPORTER STATED THAT THE WHEEL LOCKS HELD FOR A FEW DAYS WHEN THEY RECEIVED THE WHEELCHAIR IN (B)(6) 2019, THEN SHE NOTICED THAT THE CHAIR WOULD MOVE WHEN THE WHEEL LOCKS WERE ENGAGED. AT THIS TIME IT IS UNKNOWN WHAT, IF ANY MALFUNCTIONS OCCURRED. THE USER MANUAL PART NO. 1110550 PAGE 12 STATES: "ENGAGING THE WHEEL LOCKS MAY NOT PREVENT THE WHEELCHAIR FROM MOVING ON ALL FLOOR SURFACES INCLUDING THOSE THAT MAY BE WET OR SLICK. ALWAYS EXERCISE CAUTION WHEN TRANSFERRING INTO OR OUT OF THE WHEELCHAIR." PAGE 19 STATES: "WARNING DO NOT SHIFT YOUR WEIGHT OR SITTING POSITION TOWARD DIRECTION YOU ARE REACHING AS THE WHEELCHAIR MAY TIP OVER. DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE PICK THEM UP FROM THE FLOOR BY REACHING DOWN BETWEEN YOUR KNEES. DO NOT LEAN OVER THE TOP OF THE BACK UPHOLSTERY TO REACH OBJECTS BEHIND YOU, AS THIS MAY CAUSE THE WHEELCHAIR TO TIP OVER" PAGE 23 STATES: " BE CERTAIN THE WHEEL LOCKS ARE ENGAGED TO HELP PREVENT THE WHEELS FROM MOVING." SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE MOTHER REPORTED THAT HER DAUGHTER WAS IN THE TRSX58FBP WHEELCHAIR CLEANING THEIR ENTERTAINMENT CENTER. SHE BENT OVER TO PICK SOMETHING UP, AND ALLEGEDLY THE WHEEL LOCKS DID NOT HOLD. THE CHAIR TIPPED FORWARD, CAUSING HER TO FALL OUT. THE END-USER SUFFERED A FRACTURED RIGHT SHOULDER WHICH IS BEING TREATED WITH A BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332214 TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/U240 9153653564 WHEELCHAIR, MECHANICAL IOR INVAMEX MANUFACTURING NA:TRSX58FBP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention