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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Incorrect Device Or Component Shipped (2962)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: please explain what product code was initially ordered ? (b)(4). What is meant by incorrect configurations? i think he meant product. Clarify product code and lot number involved: lot # klh909, product (b)(4). Product return date and tracking number - this was sent back with your return kit.
 
Event Description
It was reported that the package included one each of the correct product and one each of the tape dispenser product usually reserved for another topical skin adhesive product. There was no procedure involved. Additional information has been requested.
 
Manufacturer Narrative
It was reported that this device is not malfunction reportable. Therefore, this medwatch report is not reportable.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6635936
MDR Text Key77441963
Report Number2210968-2017-32503
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/08/2018
Device Catalogue NumberCLR222US
Device Lot NumberKLH909
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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