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

Model Number FGA22100 0000

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Fall (1848); Head Injury (1879); No Code Available (3191)

Event Date 06/18/2017

Event Type  Injury  

Event Description

The injury/failure occurred on (b)(6)'s day 2017 - (b)(6)2017.The end-user screamed, as the initial reporter (end-user's husband) ran outside.The end-user is reported as having been in slippers, slipped on the steps, out feeding squirrels (said the word slipped & stairs) - transitioned to poor quality/thin metal.The user is reported as having hit her head, and she has a visible knot - she also aggravated a pre-existing fracture in her ankle.On (b)(6)2017, compass health brands spoke to the end-user's husband, who stated that the rollator was purchased for use to get around.The user was doing something in the kitchen when she fell - the frame broke where the wheel attached to the frame.The device involved with this event was returned to the store it was purchased from.The user is reported as being terrified to the use the product further due to the fall."serious injury" reporting classification was determined by compass health brands 7/25/2017.

Event Description

The device involved with this event was returned to compass health brands on 8/30/2017, and evaluated on 9/7/2017.The customer's complaint could be confirmed from a review of the returned device - one of the caster wheel's frame/tubing broke where it slides into the main frame, and, as a result, the wheel was able to be detached.Again, the customer's complaint could be confirmed from a review of the returned device.It was also confirmed 7/25/2017 that the user was pushing the rollator on cement & feeding squirrels at the time the event had occurred.

• 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: 6799198
• MDR Text Key: 82864961
• Report Number: 3012316249-2017-00099
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/05/2017
• Distributor Facility Aware Date: 06/19/2017
• Event Location: Home
• Date Report to Manufacturer: 10/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/05/2017
• 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: 63 YR
• Patient Weight: 64