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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON DERMABOND PRINEO

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ETHICON DERMABOND PRINEO Back to Search Results
Model Number CLR222US
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2017
Event Type  malfunction  
Event Description
The adhesive applicator was empty when opened. Package was intact.
 
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Brand NameDERMABOND PRINEO
Type of DeviceDERMABOND PRINEO
Manufacturer (Section D)
ETHICON
san lorenzo PR 00754
MDR Report Key6499860
MDR Text Key73130209
Report NumberMW5069144
Device Sequence Number1
Product Code OMD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Model NumberCLR222US
Device Lot NumberJHE242
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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