MAUDE Adverse Event Report: ADVANCED MEDICAL SOLUTIONS LTD LIQUIBAND EXCEED; TOPICAL SKIN ADHESIVE

Model Number	72014002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown if device caused or contributed to a serious injury.There is a small percentage of the population with a natural sensitivity to cyanoacrylate adhesive.This is indicated in the instructions for use (ifu).
Event or Problem Description
Occurrence of redness 2 to 3 week after the glue application, after mammary surgery.No further details at this time.

• Brand Name: LIQUIBAND EXCEED
• Common Device Name: TOPICAL SKIN ADHESIVE
• Manufacturer (Section D): ADVANCED MEDICAL SOLUTIONS LTD; western wood way; langage science park; plymouth, PL7 5 BG; UK PL7 5BG
• Manufacturer (Section G): ADVANCED MEDICAL SOLUTIONS LTD; western wood way; langage science park; plymouth, PL7 5 BG; UK PL7 5BG
• Manufacturer Contact: rebecca worthington ; western wood way; langage science park; plymouth, PL7 5-BG ; UK PL7 5BG
• MDR Report Key: 14111434
• Report Number: 9617175-2022-00015
• Device Sequence Number: 17465192
• Product Code: MPN
• UDI-Device Identifier: 10884521543430
• UDI-Public: 10884521543430
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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 Model Number: 72014002
• Device Catalogue Number: LX6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female