MAUDE Adverse Event Report: CHANG CHENG FA DRIVE; ROLLATOR

Model Number GV974BK-T

Device Problem Collapse (1099)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.The patient still has the unit.It is not available currently for evaluation.We nave photos on file.The enduser was coming around the rollator from back to front to sit down.He attempted to sit and the device and it collapsed and the front wheel fell off.The consumer fell hitting his elbow and head.He was taken to the hospital where he was diagnosed with a fractured elbow.He has a cast.Patient is being treated by an orthopaedist and receiving pain meds.He is in a cast.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA; no. 1 been ting; been-tsuoh village; chia-yi shiann, ; TW
• MDR Report Key: 8827205
• MDR Text Key: 152214945
• Report Number: 2438477-2019-00043
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383582221
• UDI-Public: 822383582221
• 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: 07/25/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: GV974BK-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Distributor Facility Aware Date: 06/07/2019
• Device Age: 3 MO
• Date Report to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 104