MAUDE Adverse Event Report: DOLOMITE AB MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number JAZZLOW

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the left side handle adjustment of the jazzlow rollator does not operate at all.The right side is very stiff to adjust.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): DOLOMITE AB; vaxjovagen 303; 343 75 dio ; SW
• Manufacturer (Section G): DOLOMITE AB; vaxjovagen 303; 343 75 dio ; SW
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4003844
• MDR Text Key: 18089599
• Report Number: 9615290-2014-00081
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAZZLOW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other