MAUDE Adverse Event Report: COMBRIDGE INTERNATIONAL COMPANY, LTD. ENDURANCE TRIGGER RELEASE WALKER; WALKR

Model Number WK401A-W5

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

Dealer states that this folding walker does not lock in place and side turns back and forth.Dealer did not provide any additional information.

• Brand Name: ENDURANCE TRIGGER RELEASE WALKER
• Type of Device: WALKR
• Manufacturer (Section D): COMBRIDGE INTERNATIONAL COMPANY, LTD.; unit 1, no. 66 yulong 3 road; dong sheng town; zhong shang city, guangdong, china 52841 4; CH 528414
• MDR Report Key: 7182665
• MDR Text Key: 97093500
• Report Number: 1056127-2018-00001
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756912611
• UDI-Public: 754756912611
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/11/2018,12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: WK401A-W5
• Device Catalogue Number: W1260-5F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Distributor Facility Aware Date: 12/15/2017
• Device Age: 1 YR
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59