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U.S. Department of Health and Human Services

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

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ETHICON, LLC DERMABOND PRINEO APPLICATOR CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Model Number PM72451B
Device Problem Stretched (1601)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2019
Event Type  malfunction  
Event Description
With attempted use of the dermabond prineo, the mesh was so tight in the device that it would stretch to the point where the product was unable to be used. Fda safety report id # (b)(4).
 
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Brand NameDERMABOND PRINEO APPLICATOR
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON, LLC
MDR Report Key8906318
MDR Text Key155017476
Report NumberMW5089111
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
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model NumberPM72451B
Device Catalogue NumberPM72451B
Device Lot NumberPCQ700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

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