MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number R726RD

Device Problem Separation Problem (4043)

Patient Problems Fall (1848); Pain (1994)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by a blind end user's caregiver, who reported that "the end user needs to be led by the handle on the rollator." the incident occurred when, while going up two steps to a landing, the wheel came off the device, causing the end user to stumble and fall over the caregiver, who was guiding her.Both were injured in the fall.The end user injured her back and the caregiver injured her shoulder and hip.They have both sought medical attention and were prescribed physical therapy.Both reportedly continue to have shoulder pain.Drive is currently investigating the incident, including attempting to retrieve the product and evaluate it.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; west of tanjialing rd; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 14978102
• MDR Text Key: 295627049
• Report Number: 2438477-2022-00041
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: R726RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2022
• Distributor Facility Aware Date: 05/03/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 55 KG