MAUDE Adverse Event Report: HL CORP DRIVE; MECHANICAL WALKER

Model Number 199

Device Problem Device Issue (2379)

Patient Problems Fall (1848); Brain Injury (2219)

Event Date 12/16/2016

Event Type  Injury  

Event Description

(b)(4) received notification of an incident involving a rollator that (b)(4) imports and distributes.Allegedly while the patient was using the rollator, the brakes did not function causing her to lose balance and fall.The unit fell on her as well.The patient went to the er and a cat scan revealed some bleeding in the brain.

• Brand Name: DRIVE
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): HL CORP; the 3rd industrial park; bitou village, song gang town; baoan district, shenzhen guangdong 51810 5; CH 518105
• MDR Report Key: 6258490
• MDR Text Key: 65038075
• Report Number: 2438477-2017-00005
• 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: 01/17/2017,12/20/2016

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: No Information
• Device Model Number: 199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Distributor Facility Aware Date: 12/20/2016
• Date Report to Manufacturer: 01/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 68