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

Model Number 6240-A

Device Problem Bent (1059)

Patient Problems Bruise/Contusion (1754); Fall (1848); Pyrosis/Heartburn (1883)

Event Date 08/31/2014

Event Type  No Answer Provided  

Event Description

Dealer stated that the right front and rear legs on a (b)(4) walker are bent inward.End user was walking with the unit when the legs bent inward, causing user to fall down, opening up his stitches from a recent pre existing leg amputation.Additional surgery may be needed.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): JUNCHENG; zhongshan ; CH
• MDR Report Key: 4093582
• MDR Text Key: 4762270
• Report Number: 1531186-2014-04143
• 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: 09/16/2014,09/03/2014

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-A
• 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: 09/16/2014
• Distributor Facility Aware Date: 09/03/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 09/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 MO
• Patient Weight: 131