MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 6300-ATA

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

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 10/21/2011

Event Type  No Answer Provided  

Event Description

End users daughter reported that within a few days of her father receiving a 6300-ata walklite walker he tripped and fell bending the frame.Daughter states that this was at no fault of the walker, unit would not open after the fall but they have already replaced the walker due to this issue.User injured the tip of his finger, got caught on the walker when he fell, had to get the tip of his finger stitched.Incident happened three years ago.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4195487
• MDR Text Key: 5036981
• Report Number: 1531186-2014-05028
• 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: Invalid Data
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/23/2014,10/21/2014

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: 6300-ATA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2014
• Distributor Facility Aware Date: 10/21/2014
• Date Report to Manufacturer: 10/23/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other