MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTEGUSEAL MICROBIAL SEALANT IS 100; MICROBIAL SEALANT (INTEGUSEAL)

Model Number	33736
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " before pacemaker implantation, cyanoacrylate scattered when a doctor shook the applicator to make cyanoacrylate exude well.The scattered cyanoacrylate came into the doctor's eye.".The physician reported feeling pain in his eye.Additionally, he followed-up with an "eye doctor soon and had his eye cleaned." the pain has diminished.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 06-jun-2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.H3 other text : device not returned.

• Brand Name: INTEGUSEAL MICROBIAL SEALANT IS 100
• Common Device Name: MICROBIAL SEALANT (INTEGUSEAL)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD; western wood way; langage science park; plymouth, devon PL7 5 BG; UK PL7 5BG
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17075423
• Report Number: 3011270181-2023-00058
• Device Sequence Number: 17814686
• Product Code: NZP
• UDI-Device Identifier: 10680651337365
• UDI-Public: 10680651337365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: 33736
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown