MAUDE Adverse Event Report: COMBO (ZHONGSHAN) MEDICAL EQUIPMENT DRIVE; WALKER, MECHANICAL

Model Number 10257BL-1

Device Problem Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/13/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by a letter from an attorney, which alleges that "the folding hinge assembly of the rollator failed as the end user sat down on the device's seat," causing the end user to fall backwards.The attorney further alleges that as a result, the end user "broke his back" and has been in a back brace since the incident.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the product through the attorney.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): COMBO (ZHONGSHAN) MEDICAL EQUIPMENT; no.6 tongxing east road; dongsheng town; zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 18348331
• MDR Text Key: 330746141
• Report Number: 2438477-2023-00150
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2023
• Distributor Facility Aware Date: 12/05/2023
• Event Location: Other
• Date Report to Manufacturer: 12/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male