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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERMOBIL, INC. SMART DRIVE PAIRED WITH TIC WATCH; WHEELCHAIR, POWERED
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PERMOBIL, INC. SMART DRIVE PAIRED WITH TIC WATCH; WHEELCHAIR, POWERED Back to Search Results
Model Number MX2-33P
Device Problems Mechanics Altered (2984); Wireless Communication Problem (3283); Key or Button Unresponsive/not Working (4063)
Patient Problems Fall (1848); Head Injury (1879); Headache (1880); Hemorrhage/Bleeding (1888); Confusion/ Disorientation (2553)
Event Date 08/20/2022
Event Type  Injury  
Event Description
I was using smart drive with tic watch (mx2-33p) i went around a corner of a building at (b)(6) boardwalk & encountered a great dane in my path.I tapped the watch twice to stop & it did not respond so i tried again but it still did not respond.I tried to avoid hitting the dog & hit a post projecting me headfirst out of the wheelchair.I was dazed, confused, and was picked up by people that seen me fall putting me back in my chair.I was bleeding from the forehead and paramedics were called.I was bandaged up but refused transportation to the hospital for further evaluation.I had a headache for a few days following the accident but didn't get evaluated for concussion.
 
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Brand Name
SMART DRIVE PAIRED WITH TIC WATCH
Type of Device
WHEELCHAIR, POWERED
Manufacturer (Section D)
PERMOBIL, INC.
MDR Report Key17109963
MDR Text Key317127334
Report NumberMW5118336
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMX2-33P
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
BACLOFEN , CREON , PREGABALIN.
Patient Age64 YR
Patient SexMale
Patient Weight50 KG
Patient RaceWhite
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