MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO. LTD. ESSENTIAL ROLLATOR

Model Number ROL850ESBK

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

Caster detached from wheeled walker frame.

• Brand Name: ESSENTIAL ROLLATOR
• Type of Device: ROLLATOR
• 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: 8696221
• MDR Text Key: 147951389
• Report Number: 1056127-2019-00002
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756131418
• UDI-Public: 754756131418
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

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: Lay User/Patient
• Device Model Number: ROL850ESBK
• Device Catalogue Number: W1700BK-14
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2019
• Distributor Facility Aware Date: 05/14/2019
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 95