MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Additional information has been requested, however not received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? name of surgery? 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? 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? 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 code and/or 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 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.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2022 and topical skin adhesive was used.On an unknown date in (b)(6) 2022, a patient that appeared to be experiencing a reaction after adhesive was placed.Redness at the incision site that appears to be increasing.Discussed option of removal and that surgeon should treat the patient as they would for similar symptoms.The reaction seemed to get worse as time went on.The reaction was described as severe redness and inflammation under and around the adhesive.Patient was put on atarax and medrol dose pack.Patient experienced itching and irritation in addition to redness.Home health nurse visited the patient on (b)(6) 2022 and removed the adhesive.Patient began to show signs of relief following the removal of the product.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 1659 gailes blvd; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15610456
• MDR Text Key: 301810220
• Report Number: 2210968-2022-08452
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• 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