MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; ROLLATOR

Model Number 146-10257BL-1

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's child, who stated that "the wheel fell off while my mother was walking." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Multiple attempts were made to retrieve the product for investigation, with no response.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17002176
• MDR Text Key: 316014888
• Report Number: 2438477-2023-00056
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00612479223158
• UDI-Public: 00612479223158
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 146-10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2023
• Distributor Facility Aware Date: 02/24/2023
• Date Report to Manufacturer: 06/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female