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

Catalog Number	CLR602US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an breast surgery on unknown date in 2024 and topical skin adhesive was used.The patient had a skin reaction with adhesive.Patient was sent to er with skin reactions.They stated they were severe allergic reactions.Patient was hospitalized on an steroid drip.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 - device not returned.Additional information provided: the supply chain and plastic coordinator reported rep that a few of the plastic surgeons are having cases of continued skin reactions with adhesive.And sent to er with skin reactions.They stated they were severe allergic reactions.There were two different product codes used by the doctors.Not sure which patients used which product codes at this time.She does have photos.And is following up with facility for more detailed information.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.- what is the procedure name? - what is the procedure date? - what date did the reaction occur on? 1- 7 days post op.- what does the reaction look like and how large of an area does the reaction cover? sending pictures.- do you have any pictures of the reaction? yes.- was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Approximately 4 patients his last year that were hospitalized on a steroid drip.- what is the most current patient status? fine now.- please specify which product was used for each patient (clr222us or clr602us)? mainly 602 but has occurred with both.- can you identify the lot number of the product that was used? no.- was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not sure ¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) dr.(b)(6).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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20518123
• Report Number: 2210968-2024-11032
• Device Sequence Number: 18113094
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: 10705031024168
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: CLR602US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Initial Report FDA Received Date: 10/23/2024
• 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