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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GARDEN CITY MEDICAL ROLLATOR 9153651315; WALKER, MECHANICAL

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GARDEN CITY MEDICAL ROLLATOR 9153651315; WALKER, MECHANICAL Back to Search Results
Model Number 1030KW
Device Problem Mechanics Altered (2984)
Patient Problem Fall (1848)
Event Type  malfunction  
Event Description
End user alleges one of the wheels in the front turns the opposite way when using.She fell over three times because of this.Basket was broken in one of the falls.Upholstery ripped due to her leg has some device on it.
 
Manufacturer Narrative
A follow up will be sent if the product or additional information is obtained.
 
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Brand Name
ROLLATOR 9153651315
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
GARDEN CITY MEDICAL
15 s. main st.
pmi - probasics - pinnacle
marlboro NJ 07746
Manufacturer (Section G)
GARDEN CITY MEDICAL
15 s. main st.
pmi - probasics - pinnacle
marlboro NJ 07746
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4762378
MDR Text Key5797480
Report Number1125779-2015-00054
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/27/2015
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 Number1030KW
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/27/2015
Initial Date FDA Received05/11/2015
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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