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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS TALL ADULT WALKLITE WALKER 9153643781; WALKER, MECHANICAL
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GENTEEL HOMECARE PRODUCTS TALL ADULT WALKLITE WALKER 9153643781; WALKER, MECHANICAL Back to Search Results
Model Number 6300-ATA
Device Problem Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported by caregiver that the brakes are worn out on the 6300-ata walker.Unit was just replaced two months ago for the same reason.End user can not sit on walker because it will roll away.He is using the walker after two hip replacements.Dealer allegedly told the caregiver that it can not be replaced again.Dealer called in and advised that end user is misusing the walker by sitting on one side of the top bars and scooting along.There is a previous complaint and walker was replaced in (b)(6) 2014.
 
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Brand Name
TALL ADULT WALKLITE WALKER 9153643781
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
GENTEEL HOMECARE PRODUCTS
liyu industry area
danzao nanhai foshan 5282 16
CH  528216
MDR Report Key4486622
MDR Text Key20375735
Report Number1531186-2015-00792
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 Distributor
Source Type Invalid Data
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 02/04/2015,01/29/2015
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 Number6300-ATA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2015
Distributor Facility Aware Date01/29/2015
Device Age6 MO
Date Report to Manufacturer02/04/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/05/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age15 MO
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