MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO. LTD. ENDURANCE TRIGGER RELEASE WALKER

Model Number WK401A-W5

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  Injury  

Event Description

Dealer reports that patient was walking on a sidewalk when the rear leg bent at the cross brace rivet.No fall or injury occurred at the time of the event.

• Brand Name: ENDURANCE TRIGGER RELEASE WALKER
• Type of Device: WALKER
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO. LTD.; unit 1, no. 66, yulong 3 road; dong sheng town; zhong shan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 10261746
• MDR Text Key: 198502790
• Report Number: 1056127-2020-00004
• 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: Other
• Type of Report: Initial
• Report Date: 07/11/2020,06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WK401A-W5
• Device Catalogue Number: W1260-5F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2020
• Distributor Facility Aware Date: 06/15/2020
• Device Age: 0 YR
• Event Location: Other
• Date Report to Manufacturer: 07/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 68