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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL
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CC HSING COMPANY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL Back to Search Results
Model Number RTL10266
Device Problem Mechanical Problem (1384)
Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Concussion (2192)
Event Date 09/12/2023
Event Type  Injury  
Event Description
Drive devillbiss healthcare was notified of an incident involving a rollator that the curb assist broke and the end user fell, cut her head and required 12 stitches.The end user was admitted to the hospital for 2 days with a concussion and 2 pints blood loss.Devilbiss is currently investigating the incident, including attempting to retrieve the device for investigation.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)
CC HSING COMPANY LIMITED
no. 1 benting
bentsuo village, sikao chiayi 26989 61
TW  2698961
MDR Report Key18095652
MDR Text Key327670509
Report Number2438477-2023-00140
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier00822383288819
UDI-Public822383288819
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/08/2023
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? Yes
Device Operator Lay User/Patient
Device Model NumberRTL10266
Device Catalogue NumberRTL10266
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2023
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2023
Distributor Facility Aware Date10/13/2023
Event Location Home
Date Report to Manufacturer11/08/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/08/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexFemale
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