MAUDE Adverse Event Report: DOLOMITE AB DUAL RELEASE FOLDING WALKER 9153638082; WALKER, MECHANICAL

Model Number 12070-43-21

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

"when walking outside suddenly left handle came off, which led to that the user falling to the ground".

Manufacturer Narrative

The futura is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occured in (b)(6).

• Brand Name: DUAL RELEASE FOLDING WALKER 9153638082
• 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 44035 ; 8003336900
• MDR Report Key: 4548037
• MDR Text Key: 5523539
• Report Number: 9615290-2015-00083
• 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: 02/10/2015

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: 12070-43-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/26/2015
• 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