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

Model Number 66550

Device Problems Break (1069); Component Falling (1105)

Patient Problems Fall (1848); Unspecified Infection (1930); Hematuria (2558)

Event Date 11/21/2013

Event Type  No Answer Provided  

Event Description

It was reported that the end user fell to the floor when the seat of the rollator cracked.End user alleges that the fall broke his catheter and the end user laid on the floor for hours and developed hematuria at the catheter site.End user was taken to the hospital where he was treated for undisclosed injuries and an infection.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): KENSTONE METAL; kunshan ; CH
• MDR Report Key: 3685957
• MDR Text Key: 4239996
• Report Number: 1531186-2014-00852
• 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: 03/17/2014,02/17/2014

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: 66550
• 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: 03/17/2014
• Distributor Facility Aware Date: 02/17/2014
• Event Location: Home
• Date Report to Manufacturer: 03/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51
• Patient Weight: 204