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 Discharge (2225); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It was reported that the patient underwent strayer procedure, calcaneal osteotomy, lateral column lengthening, fdl transfer, spring ligament repair, and 1st metatarsal osteotomy on (b)(6) 2017.Attempts have been made to retrieve the device.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.

Event Description

It was reported that a patient underwent foot surgery on (b)(6) 2017 and topical skin adhesive was used.The topical skin adhesive was covered initially by the 4x4's, synthetic padding, and cotton roll/splint.At post-op day 14 at the follow-up visit, the patient had no complaints and the wound looked pristine.During the post op visit, the patient was changed into a cast.It was then reported that the topical skin adhesive was touching the stockinette, padding and fiberglass of the cast.Seven days after having the cast put on, the patient noticed "leaking".At four weeks post op the patient went back to pa and there was dermatitis around superior lateral ankle incision and foot.The patient was prescribed oral prednisone and benadryl and the cast was removed and replaced with a boot.The patient will be to be seen weekly until dermatitis resolves.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: ¿ patient demographics: initials / id; age or date of birth; bmi ; gender- dont recall initials; ~ 20's; bmi unknown, but < 35; male.¿ patient pre-operative diagnosis and indication for surgery- post tib dysfunction; pes planus.¿ location and incision size of product application? multiple incisions.¿ please explain what is meant by the cast was ¿leaking¿? pt called and said that he had drainage coming through his cast: "leaking." ¿ what was the reason that prineo was still on patient at 4 weeks post op? we had been leaving prineo on all incisions at their 2 week post op appt and not removing it on anyone; a few colleagues indicated that they were leaving it on longer than 2 weeks to obtain continued wound closure that was needed for greater lengths of time.¿what prep was used prior to prineo use? chlora prep.¿ please describe how the adhesive was applied on the tape? apply to fill squares, then apply ~ 1/2 brush width outside of mesh.¿ how large of an area does the reaction cover? see attached pictures; the papules are circumfrential around the entire leg in the distribution of the cast.¿ did the skin reaction extend beyond the borders of the tape - yes.¿ please indicate any medical / surgical interventions performed - oral prednisone, benadryl.¿ was the product removed? yes.Was another method used to close the incision? no incision was already closed.¿ was the site cultured? if so, what bacteria were identified? no cx done.¿ is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not that they indicated pre-op although that question wasnt specifically asked ¿ were any patch or sensitivity tests performed? no.¿ what is the physicians opinion of the contributing factors to the reaction? this is a contact dermatitis +/- folliculitis; contributing factors could be the cast environment that the incision was in, however we have had other patients that we have done the same thing to w/o any reaction.¿ what is the most current patient status? healed.¿ patient pre-existing medical conditions - none.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6492411
• MDR Text Key: 72778767
• Report Number: 2210968-2017-31645
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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: 05/22/2017
• 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