MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number CLR422

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

Patient Problem Skin Irritation (2076)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information has been performed but not received.If the further details or the device are received at a later date a supplemental medwatch will be sent ¿ what is the procedure date? ¿ what date did the reaction occur on? ¿ what does the reaction look like and how large of an area does the reaction cover? ¿ do you have any pictures of the reaction? ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.¿ what is the most current patient status? ¿ can you identify the lot number of the product that was used? ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? it was noted that rx cream was prescribed, please provide details.Please describe how was the adhesive was applied.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) does the patient use or 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? additional information: please note that in the internal call the local team informed us that the adhesive is being left on the patients for four weeks.The patients typically did not present with skin reactions until after it was removed.The representatives also stated that the individuals applying the adhesive sometimes used their gloved finger tip to spread the adhesive on the mesh.Note: events reported on mw# 2210968-2020-06880 and mw#.

Event Description

It was reported a patient underwent a cabg procedure on an unknown date and topical skin adhesive was used.The patient had redness and skin irritation after adhesive removal on leg.A cream was prescribed.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10532976
• MDR Text Key: 207158931
• Report Number: 2210968-2020-06879
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163645
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention