MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; LIQUIBAND RAPID ADHESIVE 36/CS 0.8ML

Catalog Number	MSC091050
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the adhesive was used on an incision after an "excision for squamous cell cancer of skin" on the "left cheek" on (b)(6) 2024 and "later that evening" the patient had "bleeding".
Additional Manufacturer Narrative
According to the customer, the adhesive was used on an incision after an "excision for squamous cell cancer of skin" on the "left cheek" on (b)(6) 2024 and "later that evening" the patient had "bleeding".The customer reported the patient was unable to get the bleeding to stop and went to the "ed" where "more adhesive" and a new dressing was applied.The customer reported the patient "is better".No additional information is available.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Advanced medical solutions reported this event under report number 9617175-2024-00003.

• Common Device Name: LIQUIBAND RAPID ADHESIVE 36/CS 0.8ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18922252
• Report Number: 1417592-2024-00426
• Device Sequence Number: 6411092
• Product Code: MPN
• UDI-Device Identifier: 30888277728602
• UDI-Public: 30888277728602
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/18/2024

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: MSC091050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown