MAUDE Adverse Event Report: DOLOMITE AB DOLOMITE MAXI ROLLATOR 650 7331492560417; WALKER, MECHANICAL

Model Number 12070-43-21

Device Problem Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

"have a futura 600 that broke very unexpectedly the day before yesterday.The patient who had the walker was standing at the sink when the plastic that holds the wheel broke and the wheel came off completely.Luckily there was a staff in place so the patient did not fall, but squeezed his/her hand in the sink.

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 sweden".

• Brand Name: DOLOMITE MAXI ROLLATOR 650 7331492560417
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE AB; vaxjovagen 303; dio ; SW
• Manufacturer (Section G): DOLOMITE AB; vaxjovagen 303; dio ; SW
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4664632
• MDR Text Key: 5730929
• Report Number: 9615290-2015-00144
• 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: 03/13/2015

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: 03/13/2015
• Initial Date FDA Received: 04/07/2015
• 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