MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number RTL 10266 BK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 03/26/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who reported that she "caught her left middle finger in the braking mechanism.She managed to disengage her finger however it was bleeding profusely onto the floor." the end user bandaged her finger herself, and reported that healing was progressing normally.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT; 3 shenghui s. rd.; nantou town; zhongshan city, gungdong ; CH
• MDR Report Key: 14977597
• MDR Text Key: 295622390
• Report Number: 2438477-2022-00042
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383505305
• UDI-Public: 822383505305
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• 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: RTL 10266 BK
• 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: 04/08/2022
• Device Age: 9 MO
• Event Location: Other
• Date Report to Manufacturer: 05/30/2022
• 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 Sex: Female
• Patient Weight: 73 KG