MAUDE Adverse Event Report: UNKNOWN DRIVE; CHAIR WITH CASTERS

Model Number	RTLFW19RW-RD
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report received, the end user sustained "a head injury" while using a transport chair after the back rest on the "device collapsed" and caused them to fall.The end user received unspecified treatment in the emergency room.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: CHAIR WITH CASTERS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13112777
• Report Number: 2438477-2021-00082
• Device Sequence Number: 3295717
• Product Code: INM
• UDI-Device Identifier: 00822383246277
• UDI-Public: 822383246277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2021
• Report Date (Section F): 12/29/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTLFW19RW-RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2021
• 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 Sex: Female
• Date Report Sent to FDA: 12/29/2021