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 Reaction (2414); No Code Available (3191)

Event Date 10/15/2016

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) 2016; how was the device was used (what layer of tissue and how many layers applied): total knee closure; what was the location and incision size of prineo application: anterior right knee.Approx 6 inches; what prep was used prior to prineo application: chlorhexidine used prior to the knee replacement; was the prep allowed to dry prior to prineo mesh application: yes the chloroprep was dry; please describe how the adhesive was applied on the tape: the knee was bent.The prineo was placed on the knee; 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: slightly; was incision re-prepped before closure? if so, with what, if so, was the prep allowed to dry: no.It was simply cleaned with saline and dried; was a dressing placed over the incision, if so, what type of cover dressing used: yes.Dry gauze and a tegaderm; what date did the reaction occur on: it began within 2-3 days; what does the reaction look like, please provide details: large blisters; how large of an area does the reaction cover: 4-5 square inches; do you have any pictures of the reaction: yes; what was done to address the reaction: removed the prineo; what type of medication was used to treat the reaction: benadryl; what was the dosage: 25mg over the counter; when (date) was the medication administered: she started taking it when she called me on pod#3; was the product removed? was another method used to close the incision: yes.I put dermabond over the entire length of the incision after pulling off the mesh; was the site cultured, if so, what bacteria were identified: no; is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde: don¿t know; is the patient hypersensitive to pressure sensitive adhesives: she has a tape allergy; were any patch or sensitivity tests performed: no, but she would like to do some patch testing with an allergist.This is one of the reasons that we are trying to get information from you in regards to what adhesives are present on the product; can you identify the lot number of the product that was used: no; what is the physicians opinion of the contributing factors to the reaction: allergic to tape; what is the most current patient status: doing well.Blisters resolving uneventfully.Her range of motion and function are stellar; patient demographics: initials / id, age or date of birth, bmi, gender, patient pre-existing medical conditions (ie.Allergies, history of reactions): (b)(6); female; tape allergy; was prineo previously used on the patient in a previous surgery, if yes what was the outcome of previous surgery: no.

Event Description

It was reported that the patient underwent total knee procedure on (b)(6) 2016 and topical skin adhesive was used on the anterior right knee.Within 2-3 days after the procedure the patient exhibited large blisters in the area where the product was applied, approximately 4-5 square inches.The topical skin adhesive was removed and the patient was treated with 25 mg benadryl on post-operative day 3.After removing the mesh of the topical skin adhesive, a different topical skin adhesive was used over the length of the incision.The patient has a tape allergy and would like to do some patch testing with an allergist.It was reported that the patient is currently doing well, blisters resolving uneventfully and range of motion and function are stellar.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 12/05/2016.(b)(4).Additional information was requested and the following was obtained from the doctor: it was reported within the additional information received on 11/09/2016, that there were pictures of the reaction.Please provide any available photographs of the patient reaction.Was any testing performed for allergies and results? what was the location of the blister reaction in relation to prineo? if you¿re asking for more pictures.No dice there aren¿t anymore.It doesn¿t matter as the wound is very well healed.She wants to have allergy testing done.She would like to know what the adhesive is on the mesh.I looked at the material that you sent.I did not spend long looking at it, but with a cursory glance it did not appear that the type of adhesive was listed on it.The whole point was to find out what substance should she be allergy tested for.But if that is proprietary, then you are of no help to my patient.The blister reaction was directly underneath the prineo mesh.The patient is allergic to tape.She is under the impression that most tape adhesives are made from pine derivatives.And she states that she is very allergic to pine.

• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6132838
• MDR Text Key: 61084180
• Report Number: 2210968-2016-15178
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• 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: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• 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: 12/02/2016
• 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
• Patient Age: 65 YR
• Patient Weight: 96