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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 14027
Device Problem Insufficient Information (3190)
Patient Problem Ulcer (2274)
Event Date 05/28/2021
Event Type  Injury  
Event Description
Drive devilbiss healthcare was contacted regarding a reported injury involving a alternating pressure mattress low air loss system, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user reported having developed a pressure wound on her bottom prior to commencing use of the device.After approximately eight months of using the device, her caretakers began to notice the development of additional pressure wounds, and she was taken to the hospital.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive provided a replacement model to the end user, and is currently investigating the incident, including attempting to retrieve the product to evaluate it.
 
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Brand Name
DRIVE
Type of Device
LOW AIR LOSS MATTRESS
Manufacturer (Section D)
EEZCARE MEDICAL CORP
no 3-1 minquan st.
tucheng district, new taipei city 23679
CH  23679
MDR Report Key14978480
MDR Text Key295631025
Report Number2438477-2022-00046
Device Sequence Number1
Product Code FNM
UDI-Device Identifier00822383221618
UDI-Public822383221618
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 Operator Lay User/Patient
Device Model Number14027
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/11/2022
Distributor Facility Aware Date05/26/2021
Device Age13 MO
Event Location Home
Date Report to Manufacturer05/31/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexFemale
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