MAUDE Adverse Event Report: HEBEI HEALTHCARE DRIVE; ROLLATOR

Model Number R726RD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 05/06/2017

Event Type  Injury  

Event Description

(b)(4) is the initial importer of this device which is a rollator.End-user was crossing the street.At the curb the brakes reportedly failed causing her to fall on her knee.She was taken by ambulance to the hospital.Details of diagnosis and treatment are unclear.The end-user is no responsive to all inquiries.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHCARE; 1 chuayngye st; sw industral dist; matou eco industry pk, hebei 05604 6; CH 056046
• MDR Report Key: 7344862
• MDR Text Key: 102599597
• Report Number: 2438477-2018-00010
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 03/17/2018,03/16/2018

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: R726RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2018
• Event Location: Other
• Date Report to Manufacturer: 03/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 109