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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHEMENCE MEDICAL INC. EXOFIN SKIN GLUE CUTANEOUS TISSUE ADHESIVE WITH MESH

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CHEMENCE MEDICAL INC. EXOFIN SKIN GLUE CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Skin Disorders (4543); Contact Dermatitis (4546)
Event Date 07/02/2021
Event Type  Injury  
Event Description
Underwent surgery on breasts 6/28, surgeon used exofin skin glue to close incision sites. I experienced severe itching, on evening of (b)(6) 2021 but assumed it was due to healing processes. Monday, (b)(6) i removed all surgical bandages/ tape/drains and saw several pustules dotting the areas where the skin glue was placed, along with contact dermatitis, redness, inflammation and swelling. I went to the surgeon today, (b)(6) 2021 and he noted the allergy and removed all of the exofin and also noted the healing had been impeded by the glue.
 
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Brand NameEXOFIN SKIN GLUE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
CHEMENCE MEDICAL INC.
MDR Report Key12143397
MDR Text Key261014801
Report NumberMW5102429
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 Patient
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
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? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/08/2021 Patient Sequence Number: 1
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