Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.T.M. SHANGHAI MICROPORTABLE 4 WHEEL (BLUE) 9153645579; VEHICLE, MOTORIZED 3-WHEELED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.T.M. SHANGHAI MICROPORTABLE 4 WHEEL (BLUE) 9153645579; VEHICLE, MOTORIZED 3-WHEELED Back to Search Results
Model Number L-4B
Device Problems Unintended Collision (1429); Unintended Movement (3026)
Patient Problem Sprain (2083)
Event Date 05/07/2015
Event Type  Injury  
Event Description
Dealer called in and stated the consumer alleges she was just sitting on the scooter when it took off and she was not able to stop the scooter which ran into a table, a friend and the wall.Consumer states the only way they could get the scooter to stop is to take the key out.The consumer was transported to emergency room and allegedly has a sprained right leg and was released from the hospital.No injury reported on the friend the consumer allegedly ran into with the scooter.
 
Manufacturer Narrative
The device was returned and evaluated.The extended evaluation states: the complaint of the scooter accelerating on its own and not being able to stop without powering the device off was not confirmed.The drive switched functioned normally as well as the device's electronic system.However, there was plastic remnant found in the drive switch control that suggested that something may have been wedged into or hung around the drive switch, which could have cause the switch to unintendedly actuate or become stuck.
 
Event Description
Dealer called in and stated the consumer alleges she was just sitting on the scooter when it took off and she was not able to stop the scooter which ran into a table, a friend and the wall.Consumer states the only way they could get the scooter to stop is to take the key out.The consumer was transported to emergency room and allegedly has a sprained right leg and was released from the hospital.No injury reported on the friend the consumer allegedly ran into with the scooter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MICROPORTABLE 4 WHEEL (BLUE) 9153645579
Type of Device
VEHICLE, MOTORIZED 3-WHEELED
Manufacturer (Section D)
C.T.M. SHANGHAI
1158 yuan qu road
anting town
shanghai 2018 05
CH  201805
MDR Report Key4815743
MDR Text Key16546340
Report Number1531186-2015-01030
Device Sequence Number1
Product Code INI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/13/2015,06/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberL-4B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2015
Distributor Facility Aware Date06/19/2015
Device Age6 YR
Date Report to Manufacturer07/13/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient Weight67
-
-