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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PREMIERE PRO EXOFIN TISSUE ADHESIVE 1.0 ML CUTANEOUS TISSUE ADHESIVE WITH MESH

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PREMIERE PRO EXOFIN TISSUE ADHESIVE 1.0 ML CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Reaction (2414)
Event Date 11/05/2020
Event Type  Injury  
Event Description
He is postop from cervical spine surgery and develop a severe maculopapular rash originating at the incision required steroid therapy to treat. We think it is related to exofin skin glue. He is one of the many patients we¿ve encountered with this reaction. 525 global.
 
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Brand NamePREMIERE PRO EXOFIN TISSUE ADHESIVE 1.0 ML
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
MDR Report Key11177571
MDR Text Key227597900
Report NumberMW5098848
Device Sequence Number1
Product Code OMD
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
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