MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL DRIVE; WALKER

Model Number 796

Device Problem Fracture (1260)

Patient Problem Easy Bruising (4558)

Event Date 10/08/2021

Event Type  Injury  

Event Description

(b)(4) healthcare is the initial importer of the device which is a walker.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow-up when additional information is available.While in use the steering limiter piece of metal broke off.The user sustained an injury to her knee.An x-ray was performed with no fractures diagnosed.The diagnosis was just bruising.We are awaiting more information.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL; danyang lianhu industrial par; danyang city,, jangsu 21230 0; CH 212300
• MDR Report Key: 12697501
• MDR Text Key: 278370082
• Report Number: 2438477-2021-00062
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 50822383509346
• UDI-Public: 50822383509346
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/26/2021

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: 796
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2021
• Distributor Facility Aware Date: 10/11/2021
• Device Age: 40 MO
• 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): Hospitalization