MAUDE Adverse Event Report: UNKNOWN DRIVE; CHAIR WITH CASTERS

Model Number RTLFW19RW-RD

Device Problem Collapse (1099)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event 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
• Type of Device: CHAIR WITH CASTERS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13112777
• MDR Text Key: 282978886
• Report Number: 2438477-2021-00082
• Device Sequence Number: 1
• Product Code: INM
• UDI-Device Identifier: 00822383246277
• UDI-Public: 822383246277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTLFW19RW-RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2021
• Distributor Facility Aware Date: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female