MAUDE Adverse Event Report: DOLOMITE AB WALKER TRAY 9153627168; WALKER, MECHANICAL

Model Number 12070-43-21M

Device Problem Component Missing (2306)

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

Event Date 01/20/2015

Event Type  malfunction  

Event Description

Patient's walker lost the left front wheel.The patient has got the walker replaced.

Manufacturer Narrative

The futura is the same /similar to products which are manufactured and/or marketed by invacare in the u.S.The alleged incidents occured in (b)(6).

• Brand Name: WALKER TRAY 9153627168
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE AB; vaxjovagen 303; 343 75 dio ; SW
• Manufacturer (Section G): DOLOMITE AB; vaxjovagen 303; 343 75 dio ; SW
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4457328
• MDR Text Key: 5325432
• Report Number: 9615290-2015-00053
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/20/2015

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: 12070-43-21M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 01/27/2015
• 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