MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL DRIVE; ROLLATORS 4-WHEEL ALUMINUM

Model Number 795B

Device Problem Solder Joint Fracture (2324)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified on (b)(6) 2022 of an accident involving a rollator/transport chair.The end user reported that on an unknown date approximately a year ago, she was being pushed in the unit by her daughter a few years ago when the front left wheel and fork broke out of the frame, causing her to fall to the floor, hurting her back and shoulder and resulting in soreness for 1 to 2 weeks.She reported that her daughter also fell at that time and hurt her back and shoulder.The end user reported that she "had someone repair/weld the unit back together," and continued to use it for about a year, until the front left wheel broke again, causing her and her daughter to fall and injure their backs and shoulders again, resulting in soreness.Drive is attempting to retrieve the repaired unit for inspection and evaluation.

• Brand Name: DRIVE
• Type of Device: ROLLATORS 4-WHEEL ALUMINUM
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL; 3 shenghui south road; nantou town; zhongshan city, guangdong province ; CH
• MDR Report Key: 14022302
• MDR Text Key: 288677283
• Report Number: 2438477-2022-00023
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• 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: 04/06/2022

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: 795B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Distributor Facility Aware Date: 02/17/2022
• Event Location: Home
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 109 KG