MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2022 and topical skin adhesive was used.A few days post op to procedure, patient had contact dermatitis, in the form of redness intense burning and itching of the skin where the adhesive mesh is and irritation.Topical steroids were administered and that cleared the reaction.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Additional information provided: no noticeable connection in similarities with patient types.No changes in pre-op or post op care.In most dermatitis there were patient consequences.Q: what kind of irritation was it? a: focal contact dermatitis.Q: when did this start? how many patients has this reaction occurred in? a: started back in (b)(6).We finally stopped using it altogether in (b)(6).We have never had this experience before as we have been using prineo consistently for around 3 years.This happened in every single patient that we applied prineo to since (b)(6).So at least 20 patients.There was not one patient that didn't have a reaction.Q: was there any way to identify what kind of patient profile this could have an association with? a: no¿ it just happened to every one of our patients.There really wasn't a similarity in patient profile other than the fact prineo was applied to them.Q: did anything change about your practice that you can think of in terms of application? a: absolutely not.We've always dressed the site exactly the same.Nothing changed.Q: is it routine to put a dressing over the prineo? a: yes.Q: what does the patient experience when this reaction is occurring? a: an intense burning and itching of the skin q: what is the visual of the reaction area? a: very red and it¿s like a perfect ¿box¿ of exactly where the prineo was.No lateral spread of redness.In some cases patients experienced really terrible blistering.For those patients who had blistering we had to administer antibiotics to curb infection.Q: when did symptoms develop and what did you typically prescribe once a patient was experiencing these symptoms? a: generally these symptoms developed within just a few days right after application.We would have the patient take the prineo off and then utilize a topical steroids and that would clear out the reaction.Additional information has been requested and received q:did you take any pictures or record lot numbers? a: no, i didn't pay attention to any of that.Used what they gave me.Q: was there a difference in reactions from facility to facility? i know you said it was every patient since (b)(6).A: so maybe it wasn't every single case but it was a lot.At the least every other case.Still, we did have cases back to back that had reactions.It was a lot.No-- there was no distinguishing between facilities.Q: specifically what did you use to dress over top? a: just gauze and ioban.Q: to the best of your knowledge did nurses make dressing changes at any point even if just a change of gauze? a: no they did not.Please identify how many, patients have had prescription topical steroids, blisters, antibiotics? or a combination? all patients were given topical steroids.3-4 patients experienced blisters.Patients with blisters were also administered antibiotics.Q: were the topical steroids administered prescription strength for all patients? a: yes.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Name of surgery? what was the procedure date? what date /day post op was the reaction noted? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? product lot of product used? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? no product available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND PRINEO 22CM MSH ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15487061
• MDR Text Key: 300630024
• Report Number: 2210968-2022-07903
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• 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
• Patient Outcome(s): Required Intervention