BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST

    MDR report key: 8139241 · Received December 6, 2018

    Report

    Report Number
    3032618-2018-00011
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    September 17, 2018
    Report Date
    December 6, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K023606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER'S MOTHER INDICATES THAT THE CHAIR WAS BETTER SUITED FOR THE PATIENTS ABILITIES WHEN IT WAS NEW. THE CUSTOMER WAS USING A TWIST, WHICH IS A HIGHLY CONFIGURABLE PEDIATRIC PRODUCT THAT IS DESIGNED TO BE ADJUSTED IN DIMENSIONS AND SPECIFICATIONS BY THE PATIENT'S HEALTH SPECIALIST AS NECESSARY. WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET ALL SPECIFICATIONS AS ORDERED WHEN IT LEFT THE FACILITY. WE HAVE NO SHIPMENTS OF PARTS MEANT TO RECONFIGURE THE CHAIR ON RECORD FOR THE SERIAL NUMBER. WE DO NOT HAVE ANY INFORMATION ABOUT HOW THE CHAIR HAS BEEN RECONFIGURED BY THE PATIENT'S HEALTH SPECIALIST IN THE TWO YEARS IT HAS BEEN IN USE. THE ALLEGED EVENT OCCURED ON THE PLAYGROUND AT THE CUSTOMER'S SCHOOL. WE DO NOT HAVE ANY INFORMATION ABOUT THE SURFACE THE END USER WAS MOVING ON, OR THE NATURE OF THE END USER'S ACTIVITIES LEADING UP TO THE EVENT. WE DO NOT HAVE ANY DETAILS THAT EXPLAIN HOW THE END USER TIPPED FORWARD. WE PROVIDE MANY WARNINGS AND GUIDANCES IN THE OWNERS MANUAL, INCLUDING THE FOLLOWING: CHAPTER 1: WARNINGS - SECTION F. ENVIRONMENTAL FACTORS: 1. RIDING YOUR TILITE WHEELCHAIR ON WET, ICY OR OTHER SLICK SURFACES INCREASES THE RISK OF LOSING CONTROL OF THE WHEELCHAIR OR TIPPING OVER. USE EXTRA CARE IF YOU MUST RIDE YOUR CHAIR ON ANY SUCH SURFACE. IF YOU HAVE ANY DOUBT ABOUT YOUR ABILITY TO NEGOTIATE A PARTICULAR SURFACE, ALWAYS ASK FOR ASSISTANCE. SECTION H. TERRAIN: YOUR TILITE WHEELCHAIR IS DESIGNED FOR RIDING OVER FIRM, RELATIVELY SMOOTH SURFACES SUCH AS CONCRETE AND ASPHALT OUTDOORS AND INDOOR FLOORING (WOOD, TILE, ETC.) AND CARPETING. YOUR TILITE WHEELCHAIR IS NOT DESIGNED FOR RIDING OVER SAND, LOOSE SOIL OR ROUGH TERRAIN. DO NOT OPERATE YOUR CHAIR IN SUCH TERRAIN. YOU MAY DAMAGE THE WHEELS OR AXLES OR LOOSEN FASTENERS OF YOUR CHAIR. IF YOU IGNORE THESE WARNINGS, YOU MAY FALL, TIP OVER OR LOSE CONTROL OF THE WHEELCHAIR AND SERIOUSLY INJURE YOURSELF OR OTHERS OR DAMAGE THE WHEELCHAIR. SECTION G. OBSTACLES: WARNING: WHEN RIDING OUTDOORS, UNEVEN PAVEMENT, SIDEWALK IRREGULARITIES, POTHOLES AND OTHER OBSTACLES AND ROAD HAZARDS CAN BE DANGEROUS. WHEN RIDING INDOORS, DOORWAY THRESHOLDS, PLUSH CARPETING AND OTHER OBSTACLES CAN BE DANGEROUS. SECTION I. HILLS/SLOPES/RAMPS: WARNING: THE CENTER OF BALANCE OF YOUR CHAIR IS AFFECTED BY THE SLOPE OF THE SURFACE OVER WHICH YOU ARE RIDING. BECAUSE YOUR CENTER OF BALANCE WILL BE AFFECTED, YOUR CHAIR WILL BE LESS STABLE WHEN IT IS AT AN ANGLE. THIS IS ESPECIALLY TRUE WHEN RIDING ON A SLOPE SIDEWAYS. FURTHERMORE, DO NOT ASSUME ANTI-TIPS WILL PREVENT A FALL OR TIP-OVER UNDER THESE CONDITIONS. THE FOLLOWING RULES MAY HELP TO AVOID A FALL OR TIP-OVER: ALWAYS BE ALERT FOR WET OR SLIPPERY CONDITIONS OR SURFACES, ANY CHANGES IN THE GRADE OF THE SLOPE (SUCH AS A LIP, BUMP OR DEPRESSION), AND ANY DROP-OFF OR LIP AT THE BOTTOM OF A SLOPE. FOR EXAMPLE, EVEN A 2 CM LIP AT THE BOTTOM OF A RAMP CAN CAUSE THE CASTERS TO STOP AND CAUSE THE CHAIR TO TIP FORWARD. WE HAVE NOT BEEN PROVIDED ANY ADDITION INFORMATION ABOUT THE EVENT OR THE CONDITION OF THE CUSTOMER AT THIS TIME. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE END USER'S MOTHER ALLEGES THAT WHILE THE PATIENT WAS ON THE PLAYGROUND AT SCHOOL, HIS CHAIR TIPPED FORWARD AND HE INJURED HIS MOUTH, NOSE AND FACE. THE PATIENT IS DESCRIBED AS HAVING AT LEAST TWO PRE-EXISTING CONDITIONS THAT "EXASERBATED" THE EFFECTS OF THE INCIDENT; FIRST IS A REMOVAL OF THE TOP THREE VERTEBRAE ARCHES AS AN INFANT, THE SECOND BEING AN ORAL SURGERY 10 DAYS PRIOR TO THE INCIDENT. THE END USER'S MOTHER ALLEGES THAT IT WAS POSSIBLE THAT AS A RESULT OF THE INCIDENT, AN EXISTING BRAIN CATHETER BECAME DISLODGED AND CLOGGED, WHICH REQUIRED A SHUNT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979202 TWIST WHEELCHAIR IOR TISPORT, LLC TWIST

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization