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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER
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UNKNOWN DRIVE; WALKER Back to Search Results
Model Number 10210-1
Device Problem Device Slipped (1584)
Patient Problem Fall (1848)
Event Date 05/01/2019
Event Type  Injury  
Event Description
(b)(4) is the initial importer of the device which is a walker.Consumer product safety report was filed.Data was gleaned from that report only.No evaluation can be performed on the product as it is anonymous.End-user wheels are too slippery and back legs come with plastic bottle caps that had the end user sliding.Patient had just come home from post tkr (total knee replacement) surgery.She complained that the wheels were slippery.She fell while exiting the bathroom while using the device.She landed on her knee and fell backwards.Her heel met her buttock.Her incision ruptured.She had emergency surgery less than a week after the first surgery.She is on pain meds.She may have broken the bones under the prosthetic.
 
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Brand Name
DRIVE
Type of Device
WALKER
Manufacturer (Section D)
UNKNOWN
MDR Report Key8818483
MDR Text Key151946806
Report Number2438477-2019-00039
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
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/23/2019
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 Number10210-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/23/2019
Distributor Facility Aware Date05/20/2019
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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