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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS MAVIDON COLLODION REMOVER 128 OZ GALLON; SOLVENT, ADHESIVE TAPE

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MAVIDON MEDICAL PRODUCTS MAVIDON COLLODION REMOVER 128 OZ GALLON; SOLVENT, ADHESIVE TAPE Back to Search Results
Lot Number L2019E
Device Problem Nonstandard Device (1420)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  No Answer Provided  
Event Description
Product recall, collodion remover.Product recall (b)(6) 2019.
 
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Brand Name
MAVIDON COLLODION REMOVER 128 OZ GALLON
Type of Device
SOLVENT, ADHESIVE TAPE
Manufacturer (Section D)
MAVIDON MEDICAL PRODUCTS
MDR Report Key9559339
MDR Text Key174135467
Report NumberMW5092078
Device Sequence Number1
Product Code KOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/03/2020
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? No
Device Operator No Information
Device Lot NumberL2019E
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/06/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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