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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIRE-DEX LLC NON-SURGICAL LEVEL 3 ISOLATION GOWNS; NON-SURGICAL ISOLATION GOWN
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FIRE-DEX LLC NON-SURGICAL LEVEL 3 ISOLATION GOWNS; NON-SURGICAL ISOLATION GOWN Back to Search Results
Model Number MC311
Device Problem Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 10/28/2021
Event Type  Injury  
Event Description
The fire-dex non-surgical level 3 isolation gown does not have taping on the seams that prevents biohazardous fluids from passing through the seams.Fire-dex advertises this gown as meeting the aatcc 42 and aatcc 127 tests.After further investigation and testing, this gown does not meet these two tests since the seams are not covered (taped) with a material that prevents biohazardous fluids from passing through.By failing these two industry standard tests, it concludes that fire-dex is falsely advertising and marketing this product as a aami level 3 isolation gown.Please note that many of these gowns have been sold to fire responders around the united states under the false pretense that the seams will block biohazardous fluids from passing through.This item will not offer any protection to the person wearing the gown in the seam area and will contaminate the person wearing the gown.I am notifying the fda, so a recall can be issued as soon as possible.Fda safety report id# (b)(4).
 
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Brand Name
NON-SURGICAL LEVEL 3 ISOLATION GOWNS
Type of Device
NON-SURGICAL ISOLATION GOWN
Manufacturer (Section D)
FIRE-DEX LLC
780 s progress dr
medina OH 44256
MDR Report Key12738088
MDR Text Key280049627
Report NumberMW5105075
Device Sequence Number1
Product Code OEA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMC311
Device Catalogue NumberMC311
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/01/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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