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

Model Number FGA22100 0000

Device Problems Bent (1059); Break (1069); Material Integrity Problem (2978)

Patient Problems Fall (1848); Pain (1994)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

The end-user bought the unit and two weeks after the unit was bought, the leg bent and the end-user fell.The end-user was pushing the unit, and fell outside on the concrete sideways.An ambulance had to be called to help him get back up.Per the end-user, he was not injured, and the emt's helped to get him up and back into the house.The end-user complained of leg pain in both legs.After about 2 hours, the pain went away.The end-user is reported to mostly use the rollator outside - the user was walking to his truck, when the front wheel buckled and he fell.He also uses the rollator for balance, and once in awhile, his leg gives out on him, so the rollator is helpful.The device was returned to (b)(4) on 12/8/2016 & reviewed on (b)(6) 2016 - the unit was found to have a bent front caster wheel, and the tubing of the wheel that slides into the frame was found to also have bent, resulting in the unit being unstable.

• Brand Name: STEEL ROLLING WALKER
• Type of Device: ROLLATOR
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO.,LTD; unit 1, no 66 yu long 3 road; dong sheng town; zhong shan city, guangdong 52841 4; CH 528414
• Manufacturer (Section G): COM-BRIDGE INTERNATIONAL CO.,LTD; unit 1, no 66 yu long 3 road; dong sheng town; zhong shan city, guangdong 52841 4; CH 528414
• Manufacturer Contact: kevin walls
• MDR Report Key: 6412563
• MDR Text Key: 70175905
• Report Number: 3005739540-2017-00001
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 03/17/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: FGA22100 0000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention