BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGUSEAL MICROBIAL SEALANT IS 100

    MDR report key: 17075423 · Received June 6, 2023

    Report

    Report Number
    3011270181-2023-00058
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 6, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    NZP
    UDI-DI
    10680651337365
    PMA / PMN Number
    K052870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234097 INTEGUSEAL MICROBIAL SEALANT IS 100 MICROBIAL SEALANT (INTEGUSEAL) NZP AVANOS MEDICAL INC. 33736 UNKNOWN 10680651337365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown