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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 NA:65100R
Device Problem Use of Device Problem (1670)
Patient Problem Death (1802)
Event Date 05/20/2017
Event Type  Death  
Manufacturer Narrative
The lawyer said it was determined that the fall and injury were the cause of the patient's death.He stated: that the product itself is not damaged, or defective but the caregiver did not follow the warning labels or instructions that are on the product.Should additional information become available , a supplemental record will be filed.
 
Event Description
The caregiver was transporting the patient by having her sit on the seat of the 65100r rollator.They were pulling her backward across carpeting, and the rollator got stuck.The patient fell backward, suffered a skull fracture, and died a few days later.The fall and injury were determined to be her cause of death.
 
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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
guangdong, china 52821 6
CH  528216
MDR Report Key9504732
MDR Text Key172254749
Report Number1531186-2019-00010
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/18/2019,11/26/2019
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? No
Device Operator Lay User/Patient
Device Model NumberNA:65100R
Device Catalogue Number65100R
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2019
Distributor Facility Aware Date11/26/2019
Date Report to Manufacturer12/18/2019
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received12/20/2019
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) Death; Other;
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