MAUDE Adverse Event Report: JUNCHENG MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 6240-5F

Device Problem Collapse (1099)

Patient Problems Fall (1848); Discomfort (2330); Injury (2348)

Event Type  No Answer Provided  

Event Description

Dealer stated that the end user reported that he fell when his 6240-5f walker collapsed under him.End user stated that he has a fat lip from hitting his face on the walker, also reports that he landed on his knees and is banged up.User states he will be going to the doctor to get checked out.Dealer reports there is blood on the walker.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): JUNCHENG; zhongshan ; CH
• MDR Report Key: 4211379
• MDR Text Key: 4967356
• Report Number: 1531186-2014-05167
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/29/2014,10/28/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6240-5F
• 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: 10/29/2014
• Distributor Facility Aware Date: 10/28/2014
• Device Age: 16 MO
• Date Report to Manufacturer: 10/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 71