MAUDE Adverse Event Report: C.T.M. SHANGHAI MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT; 890.3800

Model Number L-3B

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848); Skin Tears (2516)

Event Date 07/25/2014

Event Type  No Answer Provided  

Event Description

The end user alleges while going up a ramp at (b)(6), the scooter wouldn't go up the ramp so she turned it around but it wouldn't go so the scooter went over the side of the ramp.She hurt her right knee, it's black and blue down to the toes, she hurt both elbows.She also hit her head on the cement and says it's scarred up.She said her dr.Came to her and took x-rays but nothing was broken.She was told to stay in her chair with her feet elevated.After the fall she evaluated the scooter and found that the weld that connects the front tiller to the frame has broken.

• Brand Name: MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
• Type of Device: 890.3800
• Manufacturer (Section D): C.T.M. SHANGHAI; 1158 yuan qu road; anting town; shanghai 2018 05; CH 201805
• MDR Report Key: 4063555
• MDR Text Key: 4896932
• Report Number: 1531186-2014-03898
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/05/2014,08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L-3B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2014
• Distributor Facility Aware Date: 08/15/2014
• Device Age: 13 MO
• Date Report to Manufacturer: 09/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100