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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLATOR 9153651315; WALKER, MECHANICAL
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GENTEEL HOMECARE PRODUCTS ROLLATOR 9153651315; WALKER, MECHANICAL Back to Search Results
Model Number 1032MAR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Laceration(s) (1946); Concussion (2192)
Event Type  Injury  
Event Description
The end user states that while using the rollator to get onto a free bus she fell and hit her head on the steps of the bus.The end user states that she was taken by ambulance to the hospital and had to have glue used to seal the gash shut.The end user also states that she was diagnosed with a concussion and was sent home from the hospital the same evening.
 
Manufacturer Narrative
It was originally reported that the subject device was an imported product manufactured by genteel homecare products.Upon further review, it was determined that the device was supplied by probasics, which was a subsidiary of invacare at the time of the alleged event.This is no longer the case.This updated information was previously submitted under manufacturing report number 1125779-2015-00128.It is now being submitted as a follow-up to the original report number.
 
Event Description
The end user states that while using the rollator to get onto a free bus she fell and hit her head on the steps of the bus.The end user states that she was taken by ambulance to the hospital and had to have glue used to seal the gash shut.The end user also states that she was diagnosed with a concussion and was sent home from the hospital the same evening.
 
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Brand Name
ROLLATOR 9153651315
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
GENTEEL HOMECARE PRODUCTS
liyu industry area
danzao nanhai foshan
MDR Report Key4821674
MDR Text Key5844627
Report Number1531186-2015-01036
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Invalid Data
Type of Report Initial,Followup
Report Date 06/02/2015,05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1032MAR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA06/02/2015
Distributor Facility Aware Date05/29/2015
Date Report to Manufacturer06/02/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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