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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET DOLOMITE MAXI ROLLATOR 650 7331492560417; WALKER, MECHANICAL
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INVACARE TAYLOR STREET DOLOMITE MAXI ROLLATOR 650 7331492560417; WALKER, MECHANICAL Back to Search Results
Model Number UNKNOWN
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.The product was returned to invacare (b)(4).However, no evaluation was available for review at the time of this investigation, so the complaint could not be verified, and the underlying cause of the complaint issue could not be determined after reviewing the documentation in this investigation.
 
Event Description
The brake is not holding.
 
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Brand Name
DOLOMITE MAXI ROLLATOR 650 7331492560417
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer (Section G)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5676037
MDR Text Key45793317
Report Number1525712-2016-01620
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 07/05/2012
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 NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2012
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/05/2012
Initial Date FDA Received05/24/2016
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
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