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

Model Number FGA22300 0000

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

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 02/22/2019

Event Type  Injury  

Event Description

In february she was in las vegas and was walking and didn't see the curb because it was dark.When she stepped off the curb she fell and the left front wheel broke.She broke her right shoulder.She went to the emergency room.She didn't call until now because she didn't need the rolling walker until now.

• Brand Name: CAREX
• Type of Device: STEP N REST ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, 22102 ; TW 22102
• MDR Report Key: 9580560
• MDR Text Key: 175049688
• Report Number: 3012316249-2020-00003
• 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: Other
• Type of Report: Initial
• Report Date: 01/13/2020

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: FGA22300 0000
• Device Catalogue Number: A223-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2020
• Distributor Facility Aware Date: 12/23/2019
• Event Location: Other
• Date Report to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 104