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

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.

• Brand Name: PREMIERE PRO EXOFIN TISSUE ADHESIVE 1.0 ML
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• MDR Report Key: 11177571
• MDR Text Key: 227597900
• Report Number: MW5098848
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/14/2021
• 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