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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DOLOMITE AB ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL
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DOLOMITE AB ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL Back to Search Results
Model Number 12070-43-21M
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 02/16/2015
Event Type  malfunction  
Event Description
"the user was born in 1928 and has dementia.When she was out walking, she become angry and frustrated when the walker got stuck in a snowdrift.Front fork on the right side came off.
 
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).
 
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Brand Name
ROLLATOR ADULT RED 9153641186
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 Key4783840
MDR Text Key15973084
Report Number9615290-2015-00188
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
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 04/24/2015
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 Number12070-43-21M
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/24/2015
Initial Date FDA Received05/20/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age87
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