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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, LLC DERMABOND PRINEO CUTANEOUS TISSUE ADHESIVE WITH MESH

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ETHICON, LLC DERMABOND PRINEO CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Model Number CLR222US
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2017
Event Type  malfunction  
Event Description
Prineo skin closure system was used during surgical case and after opening package, it appeared that the liquid adhesive had leaked out of applicator and hardened. An additional skin closure package was obtained and surgical procedure closed with any complications.
 
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Brand NameDERMABOND PRINEO
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON, LLC
highway 183
san lorenzo PR 00754
MDR Report Key7266101
MDR Text Key99908596
Report Number7266101
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Device Lot NumberLJJ259
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2018
Event Location Hospital
Date Report to Manufacturer02/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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