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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 Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Reaction (2414); No Code Available (3191)
Event Date 09/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) date sent to the fda: 09/27/2016. (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. Do you have any photos of the reaction? location and incision size of product application? what prep was used prior to prineo use? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? was the mesh placed over the entire length of the incision? was the dermabond liquid adhesive placed to cover the entire length of the mesh? did the prineo mesh extend beyond the patient incision? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? what does the reaction look like? please provide details. How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape? was the site cultured? if so, what bacteria were identified? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? lot number involved. What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). For female patients: has the patient been exposed to similar products, such as artificial nails? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that the patient underwent a total knee replacement procedure on (b)(6) 2016 and the topical skin adhesive was used. On (b)(6) 2016 the patient developed redness beyond the area the topical skin adhesive was applied. The patient has taken oral benadryl as needed to treat the reaction. The topical skin adhesive was removed at a post-op visit on (b)(6) 2016 and steristrips were applied. The patient has not received any prescription medications or additional intervention. Additional information has been requested.
 
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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
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5980312
MDR Text Key55730226
Report Number2210968-2016-13989
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 09/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
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 Received09/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/27/2016 Patient Sequence Number: 1
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