MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL HUGO; WALKER

Model Number 700-959E

Device Problem Fracture (1260)

Patient Problem Abrasion (1689)

Event Date 10/01/2021

Event Type  Injury  

Event Description

(b)(4) healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report to be timely and in an overabundance of caution.We fill submit a follow-up if additional information becomes available.While in use the rear wheel brake on the right side did not engage.He fell and sustained multiple abrasions.He went to the doctor for treatment.

• Brand Name: HUGO
• Type of Device: WALKER
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL; 3 shenghui south rd; nantou town; zhongshan, guangdong ; CH
• MDR Report Key: 12696911
• MDR Text Key: 278342615
• Report Number: 2438477-2021-00063
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754021210602
• UDI-Public: 754021210602
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/21/2021

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: 700-959E
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2021
• Distributor Facility Aware Date: 10/01/2021
• Device Age: 1 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 88