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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SICHUAN AST MEDICAL EQUIPMENT CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL
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SICHUAN AST MEDICAL EQUIPMENT CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL Back to Search Results
Model Number 700-959E
Device Problem Misassembled During Installation (4049)
Patient Problem Laceration(s) (1946)
Event Date 11/15/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident by the end user of the rollator being assembled incorrectly.The end user assembled the legs and handlebars on the incorrect side and backwards.This caused the brakes to cut her legs.The wound became infected and the doctor prescribed antibiotics.The end user was educated by drive devilbiss customer solutions on the proper installation of the legs and handlebars.The end user realized her mistake in assembly of the device.An update will be filed if additional information becomes available.
 
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Brand Name
DRIVE DEVILBISS HEALTHCARE
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
SICHUAN AST MEDICAL EQUIPMENT CO.,LTD
no.58, jin-peng road
c area, luxian industrial park
luzhou city, sichuan 64610 0
CH  646100
MDR Report Key18210454
MDR Text Key329028710
Report Number2438477-2023-00144
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier00754021210602
UDI-Public754021210602
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/27/2023
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 Number700-959E
Device Catalogue Number700-959E
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/27/2023
Distributor Facility Aware Date11/17/2023
Event Location Home
Date Report to Manufacturer11/27/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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