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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO SURGICAL SEALANT Back to Search Results
Catalog Number CLR602
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Additional evaluation summary: the actual product was received for evaluation. During the visual inspection of an unopened tray package, a hole was noted in the middle of the tyvek lid. The graphics and information are clear and legible and have not been affected by the hole. The applicator and the mesh dispenser do not present damage or defect.
 
Manufacturer Narrative
Date sent to the fda: 08/15/2017. 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.
 
Event Description
Prior to using on the patient, on (b)(6) 2017, during an unknown procedure, holes in the sterile packaging was found. There were no adverse patient consequences reported.
 
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Brand NameDERMABOND PRINEO
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC - SAN LORENZO, PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6795322
MDR Text Key106572440
Report Number2210968-2017-70020
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/07/2018
Device Catalogue NumberCLR602
Device Lot NumberKKH420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2016
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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