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

Catalog Number CLR602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.Procedure name, date of procedure, location and incision size of product application?, when did the reaction first occur ?, please provide the pictures of reaction., how large of an area does the reaction cover?, what was done to address the reaction?, date of prineo removal, was the site cultured? if so, what bacteria were identified?, is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde?, were any patch or sensitivity tests performed?, patient current condition, it is reported that 2 samples will be returned for analysis.Please provide product return date and tracking number, please provide lot number of product involved.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and topical skin adhesive was used.The patient presented a severe reaction post-operatively, three or nine days following the procedure.The patient had to return to hospital for treatment and removal of topical skin adhesive.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 06/03/2016.(b)(4).Additional information was requested and the following was obtained: procedure name - knee replacement procedure.Location and incision size of product application? length of incision 15-20cm.When did the reaction first occur? one patient reacted at 9 days.How large of an area does the reaction cover? please see pictures attached for area of reaction.What was done to address the reaction? following removal of prineo the reaction settled very quickly.Was the site cultured? if so, what bacteria were identified? site was not cultured.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? the patients had no known allergies.Patient current condition - following removal of prineo the reaction settled very quickly.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5675974
• MDR Text Key: 45789569
• Report Number: 2210968-2016-09203
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention