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 Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction (2414); No Code Available (3191)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: what is the procedure date? (b)(6) 2017.How was the device used (what layer of tissue and how many layers applied)? skin closure system, last step after monocryl skin closure.One layer applied.What was the location and incision size of prineo application? location: knee incision size: 15cm.What prep was used prior to prineo application? none.Clean wound area of dried blood with sterile water and dry prior to prineo application.Was the prep allowed to dry prior to prineo mesh application? yes.Please describe how the adhesive was applied on the tape? small short strokes.Cover entire mesh and slight out of margin of mesh.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? na.Was a dressing placed over the incision? if so, what type of cover dressing used? mepilex border post-op (dry dressing) followed by one layer of orthoban and crepe bandage for 2-3 days before discharge.What date did the reaction occur on? (b)(6) 2017.How large of an area does the reaction cover? whole prineo area and beyond.Do you have any pictures of the reaction? attached.What was done to address the reaction? remove prineo, send to dermatologist to prescribe antibiotics and steroid cream (augmentin) for 2 weeks.Were prescription steroids administered? if so, what type of medication was used to treat the reaction? flucicort cream.What was the dosage? 20mg (topical).When (date) was the medication administered? (b)(6).Were antibiotics prescribed? yes.What type of medication was used to treat the reaction? augmentin.What was the dosage? 625mg bd.When (date) was the medication administered? (b)(6).Was there any medical or surgical intervention to treat the reaction? if so, please clarify.Antibiotics and steroid cream.Was the product removed? was another method used to close the incision? yes, product removed.No other method requires because fortunately he closed skin with monocryl.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.What is the most current patient status? recovered.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) older lady.Other details can't be revealed.Was prineo previously used on the patient in a previous surgery? no.

Event Description

It was reported that a patient underwent a knee surgery on (b)(6)2017 and topical skin adhesive was used.Post operatively, on (b)(6)2017 the patient developed a rash and allergic reaction on the knee.The product was removed and the patient was treated on (b)(6)2017 with antibiotics and steroid cream for two weeks.The patient current status is recovered.Additional information has been requested.

• 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: 6628984
• MDR Text Key: 77215176
• Report Number: 2210968-2017-32474
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2017
• Initial Date FDA Received: 06/08/2017
• 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 Sequence Number: 1
• Treatment: MONOCRYL
• Patient Outcome(s): Required Intervention