MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE MEDICAL; MECHANICAL WALKER

Model Number R726RD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Headache (1880)

Event Type  Injury  

Event Description

Drive devilbiss healthcare received notification of an incident involving a walker that drive imports and distributes.The end user was using the walker when reportedly the brake cables failed causing her to fall.The end user sustained a head injury and had to seek immediate medical attention.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; no.1 chuangye street; southwest industrial district; matou, handan city, hebei 05604 6; CH 056046
• MDR Report Key: 6996801
• MDR Text Key: 90893415
• Report Number: 2438477-2017-00081
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/02/2017,10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2017
• Distributor Facility Aware Date: 10/03/2017
• Date Report to Manufacturer: 11/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 85 YR