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

Model Number 65650R

Device Problem Component Missing (2306)

Patient Problem Skin Tears (2516)

Event Date 08/15/2013

Event Type  No Answer Provided  

Event Description

It was reported that the user had a skin tear on her right leg due to missing nuts and bolts caps on a rollator.It is unknown if the user sought medical attention.After follow up, the user was said to be healing and doing well.No additional information is available.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 3593258
• MDR Text Key: 4037903
• Report Number: 1531186-2014-00372
• 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: 01/27/2014,01/17/2014

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: 65650R
• 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: 01/27/2014
• Distributor Facility Aware Date: 01/17/2014
• Date Report to Manufacturer: 01/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89
• Patient Weight: 64