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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL

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GENTEEL HOMECARE PRODUCTS ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL Back to Search Results
Model Number 65100R
Device Problem Break (1069)
Patient Problems Abrasion (1689); Fall (1848); Discomfort (2330)
Event Date 05/21/2014
Event Type  Injury  
Event Description
It has been reported by an end user that the front wheel on a 65100r rollator broke in two at the top of the wheel, and caused him to fall to the floor.The end user stated his left arm is scratched up and has a sore back.
 
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Brand Name
ROLLATOR ADULT RED 9153641186
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
GENTEEL HOMECARE PRODUCTS
liyu industry area
danzao nanhai foshan 5282 16
CH  528216
MDR Report Key4462142
MDR Text Key5398033
Report Number1531186-2015-00649
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 Patient
Type of Report Initial
Report Date 01/28/2015,05/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number65100R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2015
Distributor Facility Aware Date05/22/2014
Date Report to Manufacturer01/28/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/29/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight127
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