MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LIQUIBAND EXCEED; TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN

Model Number	LX6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, postoperatively, after an open breast procedure, the patient returned two months ago with skin reactions.The reactions followed the broad distribution of the skin prep called chloroprep.Skin prep was changed to betadine a month ago, and the patient has not had any skin reactions since.The doctor could not rule out transcortical sensory aphasia (tsa) as the cause yet but thinks it was likely due to the skin preparation.The doctor was also aware that a small percent of patients had reactions to cyanoacrylates and had seen patients with more central reactions that were probably tsa with the skin adhesive. .
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: reportability additional information: g3 additional review of the event and/or additional information received shows that medtronic is not responsible for reporting on this product and it is owned by advance medical solutions.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LIQUIBAND EXCEED
• Common Device Name: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19571062
• Report Number: 1219930-2024-02738
• Device Sequence Number: 12879252
• Product Code: MPN
• UDI-Device Identifier: 10884521543430
• UDI-Public: 10884521543430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LX6
• Device Catalogue Number: LX6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown