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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 CLR602US
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Additional information was requested and the following was obtained: was there any difficulty identifying the product: yes, there was no product code; was the label damaged in any way: no; is the actual sample or a representative sample (product from the same lot number) available for evaluation: unk at this time. The sales rep also stated that the customer told him that this has happened before, but it was unknown how many times it has happened. The product will not be returned, but it was unknown if it will be used in surgery. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The photo was reviewed as no samples were received. Based on evaluation results, there are no quality issues that could be associated with the contents of the component artwork. All quality system documentation is in place and approved to assure that the integrity of the product labeling and its traceability is maintained.
 
Event Description
It was reported that the outside of the packaging of the topical skin adhesive product has a missing product code in the labeling. The product code of the topical skin adhesive was listed on the packaging. There was no patient involvement.
 
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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 Key6373046
MDR Text Key68977849
Report Number2210968-2017-30930
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
Reporter Occupation
Type of Report Initial
Report Date 02/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/13/2018
Device Catalogue NumberCLR602US
Device Lot NumberKKH784
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2016
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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