MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD. CAREX; ROLLATOR

Model Number FGA221000000

Device Problem Unstable (1667)

Patient Problems Fall (1848); Spinal Column Injury (2081)

Event Type  Injury  

Event Description

This is the user's first fall - she fell in (b)(6) 2018 during a transfer from her lift chair to her rollator.She fell onto the couch, and an ambulance had to be called to help her.She went back to the hospital for revision surgery on her spinal fusion that she had in (b)(6).They had to go up to t2 for this surgery.There was trouble with the rollator's brakes staying locked.The user's husband had tried minor adjustments to the brake cables before she fell.She thought that the brakes were locked when she went to transfer to the rollator.It is not known if the brakes were locked or not after she fell.The user stayed in the hospital for treatment until the hospital determined that shee needed to get surgery.She's not having any treatment for her back now.

• Brand Name: CAREX
• Type of Device: ROLLATOR
• 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: 8114524
• MDR Text Key: 128717783
• Report Number: 3012683925-2018-00007
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2018

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: FGA221000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 11/29/2018
• 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): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 108