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 Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported a patient underwent a left foot surgery pes planus procedure on (b)(6) 2022 and topical skin adhesive was used.Post-op, patient had a reaction with blister.Surgeon prescribed triamcinolone acetonide 0.5% ointment.Patient responded well to treatment.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Surgery date: (b)(6) 2022, left foot surgery pes planus.Is a photo available of the patient reaction? no, but had blister post op was prescription strength medication treatment provided? triamcinolone acetonide 0.5% please describe how was the adhesive was applied.All moisture removed, articulated area if needed, placed mesh over wound and applied a thin layer of liquid over mesh to corners, use more liquid near bumps/lifts in incision, wipe down excess with sterile towel and sometimes use back of glove, let set until dry and then place what prep was used prior to, during or after adhesive use? chloroprep was a dressing placed over the incision? if so, what type of cover dressing used? 4x4 is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no known allergies to this pre op.Is the patient hypersensitive to pressure sensitive adhesives? unknown was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? unknown patient demographics: initials / id, gender, age or date of birth; bmi- patient: nb, dob: (b)(6) 2006, gender: f, bmi: (b)(6).Patient pre-existing medical conditions (ie.Allergies, history of reactions)- strawberry allergy.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes current patient status- recovered.No product is 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 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; +1(605)224-3135; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14340652
• MDR Text Key: 294756062
• Report Number: 2210968-2022-03508
• 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: Physician
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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
• Patient Sex: Female