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

Model Number ROL850ESB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2020

Event Type  malfunction  

Event Description

Per dealer, the end user was walking inside on a wood floor when the left front caster fell off.No injuries were reported.

• Brand Name: ESSENTIAL ROLLATOR
• Type of Device: ROLLATER
• 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: 10005256
• MDR Text Key: 197944628
• Report Number: 1056127-2020-00002
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756131401
• UDI-Public: 754756131401
• 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: 04/28/2020,04/03/2020

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: ROL850ESB
• Device Catalogue Number: W1700B-14
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2020
• Distributor Facility Aware Date: 04/03/2020
• Device Age: 11 MO
• Event Location: Home
• Date Report to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 136