MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO., LTD CAREX; STEEL ROLLING WALKER

Model Number FGA22100 0000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The frame broke at the weld by the front right wheel while the user was sitting on it.The user fell and hit her face on a table when she scooted up to the table.The user did not seek medical attention.The (b)(4) brands customer service representative that had communicated with this user regarding this event asked if the user moves around on the rollator normally while seated (scooting), and the user said yes - the csr advised that this is not the purpose of the rollator; informed it is meant to be seated on with the brakes engaged.The event is otherwise reported as having occurred on a carpeted surface.The device involved with this event was returned to (b)(4) and evaluated on 8/7/2017.The returned unit was found to have one of its front caster wheels detached from its tubing/frame, as well as its metal sleeve detached from its frame.

• Brand Name: CAREX
• Type of Device: STEEL ROLLING WALKER
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO., LTD; unit 1, no 66 yu long 3 road; dong sheng town; zhong shan city, 52841 4; CH 528414
• MDR Report Key: 6774144
• MDR Text Key: 82059468
• Report Number: 3012316249-2017-00095
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22100 0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2017
• Distributor Facility Aware Date: 07/13/2017
• Event Location: Home
• Date Report to Manufacturer: 08/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 100