MAUDE Adverse Event Report: MAXHEALTH CORP. CAREX STEP N REST; ROLLATOR

Model Number FGA22300 0000

Device Problems Break (1069); Unstable (1667)

Patient Problem Fall (1848)

Event Date 11/25/2018

Event Type  Injury  

Event Description

User purchased rollator in july 2017.User was sitting on the rollator, stood up to reach for something - "when went" to sit back down, the left front fork and wheel came loose from the leg, then came off the rollator, causing her to fall backwards.The rollator hit the bottom of her leg - it was bleeding at first, now her ankle & lower leg are swollen.She went to the doctor to see what was wrong with her leg.The doctor checked to make sure she didn't have a blood clot in her leg - they will be calling her to have an x-ray of the leg.The leg looks better already, but they are hoping the swelling in the leg will go down more.User said noticed that it (fork/wheel) was loose about 6 months ago & tightened it.

• Brand Name: CAREX STEP N REST
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, 221 ; TW 221
• MDR Report Key: 8169880
• MDR Text Key: 130535659
• Report Number: 3012316249-2018-00060
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22300 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2018
• Distributor Facility Aware Date: 11/26/2018
• Event Location: Home
• Date Report to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 76