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

Model Number 12070-43-21M

Device Problems Break (1069); Out-Of-Box Failure (2311)

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

Event Date 03/26/2015

Event Type  malfunction  

Event Description

Reported from invacare (b)(4) at least 4 cases where the front fork have broken in the plastic and fallen off.This will be reported to the (b)(4).

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 incidents occured in (b)(6) and involved devices that were sold in (b)(6).Return of devices has been requested.

• 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: 4724406
• MDR Text Key: 5579990
• Report Number: 9615290-2015-00173
• 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: 03/26/2015

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: 03/26/2015
• Initial Date FDA Received: 04/23/2015
• 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