MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number	CLR422US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an unknown orthopedic procedure on an unknown date and topical skin adhesive was used.Patient presented with rashes as spreading erythematous, periodic, and minimally raised lesions.Given a steroid cream and say that the reaction is cumbersome.Given a medrol steroid pack and have a more uncomfortable experience with the reaction.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4: udi: as the catalog/model number was not provided, the (01) gtin is not available.Additional information provided: the 4 surgeons having reactions are total joint and sports medicine focused.Dr informed that he has been getting 1 to 2 reactions per month for the past couple of years.One thing to note is that they mostly see reactions in total knees but have had a couple of hips throughout their 6-8 year's of using prineo.The rep do not have surgery dates because they do not want to take the time to look up the discharged patients.Do not have surgery dates because they do not want to take the time to look up the discharged patients.Was there any reported patient or user harm? yes.Did the patient/user require any medical or surgical intervention as a result of the event? yes.Description: all his patients present with rashes as spreading erythematous, periodic, and minimally raised lesions.Most are given a steroid cream and say that the reaction is cumbersome.Some are given a medrol steroid pack and have a more uncomfortable experience with the reaction.Did the patient/user require extended hospitalization as a result of the event? no.What is the patient¿s/user¿s status/outcome following the event? unknown.Was there a significant delay? no.Met with surgeon and ortho trauma first assist who closes.We reviewed application technique, pre-op assessment, post op actions, and making sure they haven¿t had tension while applying.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? description of event, symptoms, manifestation of reaction infection: i put these descriptions into original pc name of surgery? either tka, tsa or tendon repairs what was the procedure date?unknown what date /day post op was the reaction noted? usually day 3 or 4 when was the prineo product removed from the patient? immediately upon being notified were any cultures taken? results? i think cultures were taken on some but i don¿t know which ones.Please describe how was the adhesive was applied.Per the ifu how was the wound cleaned and dried prior to prineo application? clean with wet lap and dried per the surgeons/pa¿s what prep was used prior to, during or after adhesive use? they use duraprep was a dressing placed over the incision? if so, what type of cover dressing used? not sure is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not sure is the patient hypersensitive to pressure sensitive adhesives? not sure was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? not sure patient demographics: initials / id, gender, age or date of birth; bmi not sure patient pre-existing medical conditions (ie.Allergies, history of reactions) not sure has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? not sure was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not sure product code and/or lot of product used? clr222us and clr422us unk current patient status.Unknown name of surgeon? i listed these attached to the pc¿s above what is the physician¿s opinion as to the etiology of or contributing factors to this event? all think they are allergic reactions to prineo but they don¿t have reactions when using dermabond advanced.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: use dura prep and chloraprep and use wet lap and dry off.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 42CM MSH 3.8ML ADHESIVE
• Common Device Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24502544
• Report Number: 2210968-2026-02227
• Device Sequence Number: 10115404
• Product Code: OMD
• UDI-Device Identifier: 10705031240421
• UDI-Public: 10705031240421
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K163645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: CLR422US
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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