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); Inflammation (1932); Itching Sensation (1943); Rash (2033); Reaction (2414); No Code Available (3191)

Event Date 03/04/2017

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: how was the device was used (what layer of tissue and how many layers applied)? prineo/dermabond used to affix skin, after stratafix 1 used to close joint capsule, 2.0 vicryl to approximate subcutaneous tissues, 3.0 vicryl to approximate skin.What was the location and incision size of prineo application? left knees, incision approximately 20-21 cm.What prep was used prior to prineo application? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? skin is cleaned with a saline/iodine solution and dried.No iodine used if known allergy.Tape is applied from tibial (inferior) incision to proximal incision, without pulling.Dermabond applied over prineo.Prineo cut to 1 cm on either side of incision.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, by 1 cm.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? only to be cleaned with saline/iodine solution.Dried with a clean lap sponge.Was the skin prep solution wiped off and let dry before applying adhesive? yes.Was a dressing placed over the incision? if so, what type of cover dressing used? non-adhesive abd pad and wrapped with an ace wrap, once dermabond has dried completely.What was the angle of the knee during application? 90 degrees flexion, and left this way until the dermabond dries.What date did the reaction occur on? approximately 2 weeks following surgery.On (b)(6) 2017.What does the reaction look like? please provide details.Contact dermatitis reactions in the shape of prineo, with blistering around prineo margins and redness.The second reaction developed with itching and some blistering around the margins of prineo, followed by removal of the epidermis at the proximal wound.How large of an area does the reaction cover? the length is ~ 20-22 cm, with width the width of the prineo strip.What was done to address the reaction? immediate removal of prineo in both cases.With dry, non-adherent dressing, 4 x 4's and mesh stocking applied.The 2nd reaction will be sent to wound care for further management.Were prescription steroids administered? if so, what type of medication was used to treat the reaction? what was the dosage? when (date) was the medication administered? were antibiotics prescribed? what type of medication was used to treat the reaction? -for the second reaction only, keflex 500 mg bid x 10 days.What was the dosage? 500 mg when (date) was the medication administered.- started yesterday.Was there any medical or surgical intervention to treat the reaction? if so, please clarify.None.Was the blister drained or aspirated? was the product removed? was another method used to close the incision? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? no.Can you identify the lot number of the product that was used? unknown at this time.What is the most current patient status?.

Event Description

It was reported that the patient underwent a total knee arthroplasty procedure on (b)(6) 2017 and the topical skin adhesive was used on the left knee to affix skin from tibial/inferior incision to proximal incision, without pulling.Non-adhesive pad was placed over the incision and wrapped with an ace wrap, once topical skin adhesive has dried completely.Approximately two weeks post-op, on (b)(6) 2017, the patient presented with blistering rash like reaction from topical skin adhesive.It was also reported that the patient possibly experienced itching, redness and contact dermatitis reaction with blistering around mesh margins followed by removal of the epidermis at the proximal wound.The topical skin adhesive was immediately removed and the patient possibly was sent to wound care for further management.The reaction was possibly treated by keflex 500mg bid for ten days.No further information available at this time.

Manufacturer Narrative

The following additional information was received: the customer reports that the patient has a known skin condition (dermatographia) which was presented after the fact.Patient was put on antibiotics and seen by wound care and is doing well.

• 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: 6437151
• MDR Text Key: 70968893
• Report Number: 2210968-2017-31367
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• 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: 04/10/2017
• 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
• Treatment: STRATAFIX, 2.0 & 3.0 VICRYL
• Patient Outcome(s): Required Intervention