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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EEZCARE MEDICAL CORP DRIVE; LOW AIR LOSS MATTRESS
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EEZCARE MEDICAL CORP DRIVE; LOW AIR LOSS MATTRESS Back to Search Results
Model Number 14029
Device Problem Insufficient Information (3190)
Patient Problem Ulcer (2274)
Event Type  Injury  
Event Description
Drive devilbiss healthcare was contacted regarding a reported injury involving a bariatric low air loss mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user reported developing a pressure sore while using the device.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive has attempted to contact the end user to gather additional information and retrieve the product for evaluation, but there has been no response.Drive will file an update if additional information becomes available.
 
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Brand Name
DRIVE
Type of Device
LOW AIR LOSS MATTRESS
Manufacturer (Section D)
EEZCARE MEDICAL CORP
3-1 minquan st.
tucheng district, new taipei city 23679
CH  23679
MDR Report Key14977335
MDR Text Key295619671
Report Number2438477-2022-00051
Device Sequence Number1
Product Code FNM
UDI-Device Identifier00822383110820
UDI-Public822383110820
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 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number14029
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/11/2022
Distributor Facility Aware Date03/31/2022
Device Age9 YR
Event Location Home
Date Report to Manufacturer06/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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