MAUDE Adverse Event Report: Ethicon Inc. DERMABOND PRINEO; Surgical Sealant

Catalog Number	CLR602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Date of Event	08/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure and topical skin adhesive was used.The patient has already used the product in previous surgery without any reaction, indicating unprecedented sensitivity at this time.Chronology: (b)(6) 2026: surgery with application of the product in the incision.(b)(6) 2026: early erythema and severe itching on site.No improvement with oral antiallergic.(b)(6) 2026: reaction became systemic by the body.Emergency care with intravenous and intramuscular medication.Severe allergic rebound occurred after 8h, requiring new emergency care.Current situation: local injury (burning aspect).The surgeon removed the glue mechanically.Due to the severity of the skin, it was necessary to follow up with a dermatologist.The patient follows treatment to contain the allergy being accompanied by surgeon and dermatologist.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No contact information was provided, therefore, no additional information can be requested at this time.

• Brand Name: DERMABOND PRINEO
• Common Device Name: 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 PR 00754 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50549722
• Report Number: 2210968-2026-08892
• Device Sequence Number: 21399052
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K082289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CLR602
• Device Lot Number: 10DMAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown