• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER Back to Search Results
Model Number R726BK
Device Problem Mechanical Problem (1384)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/05/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who reported that the front wheels continued to move while the brakes were locked.The end user did not fall, but reported that because she continued to hold onto the rollator when it was moving, she experienced a sharp pain in her previously replaced elbow and was diagnosed with a complex fracture and referred to an elbow specialist.Drive devilbiss healthcare is currently investigating the incident, however the end user refused to return the device for evaluation.An update will be filed if additional information becomes available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DRIVE DEVILBISS HEALTHCARE
Type of Device
WALKER
Manufacturer (Section D)
COM-DA HEALTHCARE CO.,LTD
no. 1, jinzhao street, west
district, no. 6 workshop ii
zhongshan city, guangdong
CH 
Manufacturer (Section G)
COM-DA HEALTHCARE CO.,LTD
no. 1, jinzhao street, west
district, no. 6 workshop ii
zhongshan city, guangdong
CH  
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key18253281
MDR Text Key329554083
Report Number3014944996-2023-00009
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier00822383240664
UDI-Public822383240664
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/02/2023
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 Model NumberR726BK
Device Catalogue NumberR726BK
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/02/2023
Initial Date FDA Received12/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient SexFemale
-
-