MAUDE Adverse Event Report: KENSTONE METAL MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 65350GR

Device Problem Out-Of-Box Failure (2311)

Patient Problem Abrasion (1689)

Event Date 05/01/2014

Event Type  No Answer Provided  

Event Description

End users daughter stated the caps are missing from hardware and it has scratched her grandmother arms and legs.The grandmother is on antibodies to prevent infections.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): KENSTONE METAL; kunshan ; CH
• MDR Report Key: 3947950
• MDR Text Key: 20755886
• Report Number: 1531186-2014-02647
• 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
• Type of Report: Initial
• Report Date: 07/21/2014,06/12/2014

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: 65350GR
• 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: 07/21/2014
• Distributor Facility Aware Date: 06/12/2014
• Date Report to Manufacturer: 07/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 DA
• Patient Weight: 27