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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP DRIVE; ROLLATOR
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HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP DRIVE; ROLLATOR Back to Search Results
Model Number R800BK
Device Problem Human-Device Interface Problem (2949)
Patient Problem Laceration(s) (1946)
Event Date 05/29/2018
Event Type  Injury  
Event Description
(b)(4) is the initial importer of the device which is a rollator.(b)(4) was informed of the incident by an attorney who has since dropped the investigation.We do not forsee acquiring the rollator for examination.End-user resided home alone.She had health issues that required her to take coumadin, a blood thinning medication.She was using the rollator to get up from the couch to retrieve a blanket on a nearby sofa.The inside of her right leg came into contact wiith a sharp metal tab thae was part of the brake system.She suffered a serious laceration.The laceration required stitches, wound care and an inpatient stay at the hospital.
 
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Brand Name
DRIVE
Type of Device
ROLLATOR
Manufacturer (Section D)
HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP
liaoan village, wanshi town
fuyang district
hangzhou city, zhejiang 31140 6
CH  311406
MDR Report Key8445265
MDR Text Key139607446
Report Number2438477-2019-00010
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier00822383548579
UDI-Public822383548579
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2019,03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberR800BK
Device Catalogue NumberR800BK
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/21/2019
Distributor Facility Aware Date01/30/2019
Device Age2 YR
Event Location Home
Date Report to Manufacturer03/22/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age88 YR
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