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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); Irritation (1941); Rash (2033); Seroma (2069); Swelling (2091); Reaction (2414); No Code Available (3191)
Event Date 07/28/2016
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. Additional information was requested and the following was obtained: what is the procedure date? (b)(6) 2017 how was the device was used (what layer of tissue and how many layers applied)? skin, one layer what was the location and incision size of prineo application? right hip, 15 cm what prep was used prior to prineo application? chloraprep was the prep allowed to dry prior to prineo mesh application? yes please describe how the adhesive was applied on the tape? per instructions was the mesh placed over the entire length of the incision? yes was the dermabond liquid adhesive placed to cover the entire length of the mesh? yes did the prineo mesh extend beyond the patient incision? yes was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? no was the skin prep solution wiped off and let dry before applying adhesive? n/a was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex what date did the reaction occur on? one week post op what does the reaction look like? please provide details. Irritation, redness, swelling how large of an area does the reaction cover? 5cm ¿ 10cm out from wound edges please provide any available pictures of the reaction none was any type of medication was used to treat the reaction? no a. What was the dosage? b. When (date) was the medication administered? was the product removed? was another method used to close the incision? yes, yes wound vac/seroma was the site cultured? if so, what bacteria were identified? no is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no is the patient hypersensitive to pressure sensitive adhesives? no were any patch or sensitivity tests performed? no can you identify lot number of the product that was used? no. Is the product or representative sample (product from the same lot number) available for evaluation? no.
 
Event Description
It was reported that the patient underwent a total hip replacement on (b)(6) 2016 and topical skin adhesive was used in one layer on skin tissue of the right hip. The incision was not re-prepped before closure. One week post-op, the patient experienced a reaction such as irritation, rash, redness and swelling, and the topical skin adhesive was removed. It was also reported that the patient developed seroma and incision and drainage procedure with wound vac was performed on (b)(6) 2016.
 
Manufacturer Narrative
Additional information was requested and the following was obtained: any update to the patient current condition ¿ saw the patient yesterday and they were fine. 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 additional information? do you have any photos?.
 
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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 Key5939025
MDR Text Key54294951
Report Number2210968-2016-13467
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2016
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 Treatment Data
Date Received: 09/09/2016 Patient Sequence Number: 1
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