INVAMEX TRSX5/WD06/ADULT/28FB/BH16/1228/U2222C/COM/U240 9153637777; WHEELCHAIR, MECHANICAL
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Model Number TRSX5 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Should additional information become available for the patient a supplemental record will be filed.
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Event Description
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The dealer states that the composite part of the wheel appears very choppy cut and has potential injury if used.Per the technician's evaluation, the composite wheels have burrs on them.
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Manufacturer Narrative
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Additional/updated information was added to reflect the device receiving an expanded evaluation.The result of the evaluation was that inspection of the wheelchair's push-rim wheels found flashing on both sides of the inner wheel rim on both wheels, along with residual burrs and injection molding gate bases, which confirmed the complaint of the wheels appearing "choppy".Both wheels appeared to have not been properly deburred.The plastic burrs were all small and relatively dull.The molding gate bases were qualitatively analyzed for sharpness by passing a gloved finger over each in both directions multiple times.In each test, the glove material did not cut, tear, or abrade despite pressing forcefully, so it is unlikely that any of the molding gates or burrs could have easily caused a cut injury.They also did not impact the functionality of the wheels.
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Event Description
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The dealer states that the composite part of the wheel appears very choppy cut and has potential injury if used.Per the technician's evaluation, the composite wheels have burrs on them.Per the expanded evaluation report, inspection of the wheelchair's push-rim wheels found flashing on both sides of the inner wheel rim on both wheels, along with residual burrs and injection molding gate bases, which confirmed the complaint of the wheels appearing "choppy".Both wheels appeared to have not been properly deburred.The plastic burrs were all small and relatively dull.The molding gate bases were qualitatively analyzed for sharpness by passing a gloved finger over each in both directions multiple times.In each test, the glove material did not cut, tear, or abrade despite pressing forcefully, so it is unlikely that any of the molding gates or burrs could have easily caused a cut injury.They also did not impact the functionality of the wheels.
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Search Alerts/Recalls
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