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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN ROLLATOR 9153651315; WALKER, MECHANICAL
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UNKNOWN ROLLATOR 9153651315; WALKER, MECHANICAL Back to Search Results
Model Number UNKNOWN
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The patient was out walking on a street in (b)(6) when the front fork suddenly went off and the wheel came off.Nothing happened as the patient stopped immediately when the walker broke.Old walker from 2001.Symphony 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 occurred in (b)(6).
 
Event Description
The patient was out walking on a street in (b)(6) when the front fork suddenly went off and the wheel came off.
 
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Brand Name
ROLLATOR 9153651315
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
UNKNOWN
OH
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 Key6010410
MDR Text Key57296045
Report Number1525712-2016-02723
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 09/26/2016
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 09/26/2016
Initial Date FDA Received10/07/2016
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
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