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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 Problems Material Discolored (1170); Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2018
Event Type  malfunction  
Event Description
Circulator opened product to be handed off to sterile field but noticed applicator tip was discolored. Upon further inspection it appears that the reservoir had already been activated and liquid the had hardened. Applicator was still in neutral position indicating it had not been twisted manually to activate and may have been a failure in packaging or handling.
 
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Brand NameDERMABOND PRINEO
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON, LLC
route 22 west
p.o. box 151
somerville NJ 08876
MDR Report Key7905080
MDR Text Key121586994
Report Number7905080
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Device Lot NumberMGH486
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/05/2018
Event Location Hospital
Date Report to Manufacturer09/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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