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

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?.

• 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: 5939025
• MDR Text Key: 54294951
• Report Number: 2210968-2016-13467
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• 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 Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention