MAUDE Adverse Event Report: UNKNOWN DRIVE; POWER MOBILITY

Model Number	2850HD-22
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a power chair.The end-user had the seat for approximately a year, he noticed a tear in the seat in december but continued to use the device.Provider called stating an end user suffered an injury using the trident hd.End user was reclining the chair when all of a sudden he was cut in the back by what they believe is the seat reclining mechanism.It punctured through the back seat somehow, and cut (b)(6) leaving about a 2" gash.He went to the hospital to get treated and received stitches.(b)(6) went to the hospital and received 3 butterfly stitches while he is currently on blood thinners.

• Brand Name: DRIVE
• Common Device Name: POWER MOBILITY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8426005
• Report Number: 2438477-2019-00007
• Device Sequence Number: 16593378
• Product Code: ITI
• UDI-Device Identifier: 00822383531069
• UDI-Public: 822383531069
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2019
• Report Date (Section F): 03/15/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2850HD-22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/19/2019
• Device Age: 13 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Weight: 178
• Date Report Sent to FDA: 03/15/2019