MAUDE Adverse Event Report: COVIDIEN SURGICAL 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 Codes	Abscess (1690); Hypersensitivity/Allergic reaction (1907)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the closing (skin) step of a laparoscopic appendectomy, the use of skin adhesion was associated with a tissue reaction characterized by skin irritation, postoperative skin reaction, and delayed contact allergy to the surgical glue.Raised erythematous vesicles and pustules were observed surrounding areas of surgical glue and disseminating around these areas on the left abdomen.Additional symptoms included redness, itchiness, and bumps at the incisional sites.The patient, who had a medical history of eczema and migraines, reported feeling generally well since surgery except for concern about the redness and itchiness at the incisional sites, which were first noticed two weeks after surgery.The patient denied fever, and no obvious signs of infection, increased warmth, or tenderness were noted on physical examination by healthcare professionals at the postoperative visit.Treatment included topical hydrocortisone and benadryl creams, oral benadryl and generic claritin as needed, ice application, and bandaging for irritation from clothing protection.
Additional Manufacturer Narrative
Additional information: b3, b5, e1, e3, g3, h3 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.
Event or Problem Description
It was reported that during the closing (skin) step of a laparoscopic appendectomy, the use of skin adhesion was associated with a tissue reaction characterized by skin irritation, postoperative skin reaction, and delayed contact allergy to the surgical glue.Raised erythematous vesicles and pustules were observed surrounding areas of surgical glue and disseminating around these areas on the left abdomen.Additional symptoms included redness, itchiness, and bumps at the incisional sites.The patient, who had a medical history of eczema and migraines, reported feeling generally well since surgery except for concern about the redness and itchiness at the incisional sites, which were first noticed two weeks after surgery.The patient denied fever, and no obvious signs of infection, increased warmth, or tenderness were noted on physical examination by healthcare professionals at the postoperative visit.Treatment included topical hydrocortisone and benadryl creams, oral benadryl and generic claritin as needed, ice application, and bandaging for irritation from clothing protection.

• Brand Name: LIQUIBAND EXCEED
• Common Device Name: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23302524
• Report Number: 1219930-2025-04712
• Device Sequence Number: 11958025
• Product Code: MPN
• UDI-Device Identifier: 10884521543430
• UDI-Public: (01)10884521543430(17)260728(10)P00233853
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/21/2025

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 Expiration Date: 07/28/2026
• Device Model Number: LX6
• Device Catalogue Number: LX6
• Device Lot Number: P00233853
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/21/2025
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 90 KG