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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS MECHANICAL WALKER, ROLLATOR; 890.3825
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GENTEEL HOMECARE PRODUCTS MECHANICAL WALKER, ROLLATOR; 890.3825 Back to Search Results
Model Number 65100
Device Problem Detachment Of Device Component (1104)
Patient Problems Fall (1848); Concussion (2192); Discomfort (2330)
Event Date 10/13/2014
Event Type  No Answer Provided  
Event Description
Daughter of end user reported that her mother was using the (b)(4) walker when the left side bolt that goes into the wheel housing sheered off, caused her mother to fall, hurt her back and alleging that her right toe might be broken, no medical attention.Daughter stated that she called the doctor and was prescribed pain meds.Dealer called invacare later the same day, reported that end user reported a concussion after the wheel broke off, and was provided with pain medication from the emergency room.
 
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Brand Name
MECHANICAL WALKER, ROLLATOR
Type of Device
890.3825
Manufacturer (Section D)
GENTEEL HOMECARE PRODUCTS
liyu industry area
danzao nanhai foshan 5282 16
CH  528216
MDR Report Key4187789
MDR Text Key5160136
Report Number1531186-2014-04974
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 Invalid Data
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 10/21/2014,10/14/2014
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 Number65100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2014
Distributor Facility Aware Date10/14/2014
Device Age10 YR
Date Report to Manufacturer10/21/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age87 YR
Patient Weight91
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