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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND WITH PRINEO CUTANEOUS TISSUE ADHESIVE

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ETHICON INC. DERMABOND WITH PRINEO CUTANEOUS TISSUE ADHESIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Rash (2033); Swelling (2091)
Event Date 06/18/2018
Event Type  Injury  
Event Description
After knee replacement, dermabond and surgical mesh was used to close the wound. Within two days the leg and knee (about 30% of the skin) was inflamed with multiple blisters. A rash formed and spread over most of the body. Five weeks later, the rash continues to spread.
 
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Brand NameDERMABOND WITH PRINEO
Type of DeviceCUTANEOUS TISSUE ADHESIVE
Manufacturer (Section D)
ETHICON INC.
MDR Report Key7725642
MDR Text Key115398071
Report NumberMW5078639
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
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: 07/26/2018 Patient Sequence Number: 1
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