• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Catalog Number CLR602US
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2016
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Additional information: malfunction. 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
It was reported that a patient underwent a breast reconstruction procedure on (b)(6) 2016 and topical skin adhesive was used. The package product code was labeled differently on the peel pack than the actual product in the package. The procedure was completed using the device in the package. There were no adverse patient consequences reported.
 
Manufacturer Narrative
A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Photo analysis: there was no sample received for analysis. Only a picture of the sample was received for analysis. During photo evaluation it was observed that the tyvek lid was incorrect. This is considered incorrect and/or missing labeling. An investigation has been initiated to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6226858
MDR Text Key64016308
Report Number2210968-2017-30095
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
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 12/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2018
Device Catalogue NumberCLR602US
Device Lot NumberKJQ794
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 Received01/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-