MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD. CAREX; STEEL ROLLING WALKER

Model Number FGA22100 0000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Loss of Vision (2139)

Event Type  Injury  

Event Description

The end-user was in the restroom and was sitting on the device and fell backwards, while seated, and hit his head.He had glaucoma surgery a few years ago in his left eye and had a tube put in to drain fluid.When he hit his head the fluid was forced from his head to his eye and caused the back of his eye to collapse and he is now blind in the left eye because of this.He sought medical attention.Not sure if the blindness is permanent as of yet.The end-user continued to use the rollator.The end-user said there was no defect with the device that caused the end user to fall, he just fell.He states he fell sometime around (b)(6), 2018.

• Brand Name: CAREX
• Type of Device: STEEL ROLLING WALKER
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.; no. 58 yu long 3 road; dong sheng town; zhong shan city, guangdong ; CH
• Manufacturer (Section G): AID-PRO HEALTHCARE CO., LTD.; no. 58 yu long 3 road; dong sheng town; zhong shan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7688534
• MDR Text Key: 114008436
• Report Number: 3012683925-2018-00004
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2018

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: 07/14/2018
• Initial Date FDA Received: 07/14/2018
• 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): Other
• Patient Age: 90 YR
• Patient Weight: 111