MAUDE Adverse Event Report: HL CORP DRIVE MEDICAL; MECHANICAL WALKER

Model Number 10215RD-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 06/24/2017

Event Type  Injury  

Event Description

Drive devilbiss healthcare received notification of an incident regarding a rollator that drive imports and distributes.The enduser was attempting to sit down on the rollator when allegedly the right side brake did not enage causing her to fall and break her shoulder.She was taken to mercy hospital carthage for treatment.Drive has evaluated the unit and confirmed the brakes were not engaging when pushed downwards.However, the manual states the brakes can be adjusted to engage properly.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): HL CORP; the 3rd industrial park; bitou village, song gang town; baoan district, 51810 5; CH 518105
• MDR Report Key: 6813553
• MDR Text Key: 83461291
• Report Number: 2438477-2017-00069
• 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: 08/23/2017,07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10215RD-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2017
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Home
• Date Report to Manufacturer: 08/23/2017
• 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: 58 YR
• Patient Weight: 181