MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Catalog Number	CLR602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a breast procedure on (b)(6) 2025 and topical skin adhesive was used.Patient had a reaction to adhesive, used in breast case.Reaction occurred immediately on application of the glue to the mesh, reaction, red skin and hives.Dressing applied and then glue.Almost immediately noticed an erythematous reaction to the skin around the dressing.I watched the erythema convalesce and extend for around one minute.I then made the decision to remove the dressing.Adhesive was removed in theatre and skin washed with saline however inevitably the glue will have remained on the skin.Usual alternative dressings applied (mepilex border).Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: i think it is more likely to be a wound infection rather than dressing reaction as she had the preneo on both sides but only had the reaction on one side.Awaiting further information from surgeon regarding dates for each event.Patient today had no known previous allergies.Was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? reaction, red skin and hives.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.If yes, describe: reaction to product.Is the patient part of a clinical study: unknown.Additional information has been requested and received.Date of the event: 3.7.25 hospital name: (b)(6).Product name: dermabond prineo.Product code: clr602.Lot/batch/exp: lot-102zqg (3rd july).Event outcome/how was it managed?: the prineo tape was removed in theatre and skin washed with saline however inevitably the glue will have remained on the skin.Usual alternative dressings applied (mepilex border).Was there any consequence to the patient due to the event?: too early to say but no immediate anaphylaxis.Was the surgery prolonged due to the event? if yes, confirm: how many minutes delay: - approx 10 minutes for observation and subsequent dressing change.Is the product available for return?: no, it was discarded.Please give a detailed explanation of the event: dressing applied and then glue.Almost immediated i noticed an erythematous reaction to the skin around the dressing.I watched the erythema convalesce and extend for around one minute.I then made the decision to remove the dressing.When did the reaction present (how long after surgery?): immediately.What were the characteristics of the reaction?: redness to the skin around the dressing is product available to return for analysis.The products are not available for return unfortunately.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Which layer of tissue was infected? is photo available of patient infection? description of event, symptoms, manifestation of infection.Name of breast surgery? was any prescription strength medication prescribed to treat? please specify? were any cultures taken? results? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? 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? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? a manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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 60CM MSH 3.8ML ADHESIVE
• 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 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22804796
• Report Number: 2210968-2025-09338
• Device Sequence Number: 7657074
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: (01)10705031024168(17)260731(10)102ZQG
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: CLR602
• Device Lot Number: 102ZQG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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