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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET ROLLATOR 9153651315; WALKER, MECHANICAL
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INVACARE TAYLOR STREET ROLLATOR 9153651315; WALKER, MECHANICAL Back to Search Results
Model Number UNKNOWN
Device Problem Crack (1135)
Patient Problem No Information (3190)
Event Date 05/13/2015
Event Type  malfunction  
Event Description
Staff discovered that the walker front fork was cracked.
 
Manufacturer Narrative
The futura is the same /similar to all rollators which are, or have been manufactured and/or marketed by invacare in u.S.Rollators / rollites.The function(s) are the same, they all have brakes and locking mechanisms, the biggest difference would be 3 wheel vs.4 wheel.This alleged incident occurred in (b)(6).
 
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Brand Name
ROLLATOR 9153651315
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 Key4944851
MDR Text Key6196615
Report Number1525712-2015-03944
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 07/02/2015
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/02/2015
Initial Date FDA Received07/28/2015
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 Number1
Patient Outcome(s) Other;
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