MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problems Erythema (1840); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.(b)(4): patient 1.Patient received a "steroid".What date did the reaction occur on? on (b)(6) 2022.What does the reaction look like and how large of an area does the reaction cover? redness, rash, and erythema under the mesh.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (re-operation; re-closure; wound debridement)? if so, please specify.If medication was prescribed, please clarify if it was prescription strength.A "steroid" per the surgeon.What is the most current patient status? -skin reaction fully resolved as of (b)(6) 2022.Can you identify the lot number of the product that was used? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Was any surgical intervention performed? no.Please describe how was the adhesive was applied.The dermabond prineo was applied per the ifu's directed technique per the surgeon and his pa.What prep was used prior to, during or after adhesive use? unknown at this time.Was a dressing placed over the incision? if so, what type of cover dressing used? no per the surgeon and his pa.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no per the surgeon and his pa.Is the patient hypersensitive to pressure sensitive adhesives? no per the surgeon and his pa.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no per the surgeon and his pa.Patient demographics: initials/ id, gender, age or date of birth; bmi? unknown at this time.Patient pre-existing medical conditions (ie.Allergies, history of reactions)? unknown at this time.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown at this time.No product is available for return.

Event Description

It was reported a patient underwent a total knee arthroscopy procedure on an 3/21/2022 and topical skin adhesive was used.Patient had a skin reaction several days post-op.Patient presented with redness, rash, and erythema per the surgeon.Patient received a steroid reaction resolved after removing the adhesive.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML 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
• MDR Report Key: 14428834
• MDR Text Key: 291932141
• Report Number: 2210968-2022-03791
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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: 04/19/2022
• 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