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

Model Number RTL10266DT

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will submit a follow up when additional information is available.The end-user walked into the motionless device on the jetway.She gauged her leg about 6 inches long.An ambulance came to take her to the er.The er doctor was unable to completely sew up the injury.He gave her 4 stitches and instructed her not to get it wet.She was sent to a wound care specialist who added additional stitches to the wound.He defined the injury as an avulsion laceration.Antibiotics were prescribed to prevent infection.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO LTD; 3 shenghui south road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 12495609
• MDR Text Key: 272167977
• Report Number: 2438477-2021-00045
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383972497
• UDI-Public: 822383972497
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/20/2021

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: Lay User/Patient
• Device Model Number: RTL10266DT
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2021
• Distributor Facility Aware Date: 08/30/2021
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention