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

Model Number ROL850ESR

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Event Description

The front caster assembly fell off while use was walking in her kitchen.No fall or injury occurred.

• 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: 9947275
• MDR Text Key: 197944987
• Report Number: 1056127-2020-00001
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756131425
• UDI-Public: 754756131425
• 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: 04/09/2020,03/24/2020

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: ROL850ESR
• Device Catalogue Number: W1700R-14
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2020
• Distributor Facility Aware Date: 03/24/2020
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 04/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 104