BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CFD-22102

    MDR report key: 12071520 · Received June 25, 2021

    Report

    Report Number
    2020601-2021-00003
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 25, 2021
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    PMA / PMN Number
    K060249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH CFD-22102, LOT # 324268 WAS REVIEWED AND THERE WERE NO ANOMALIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH WOULD CONTRIBUTE TO THIS TYPE OF FAILURE. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY HAS REVEALED THAT THIS DEVICE IS PERFORMING AS EXPECTED. MICROAIRE WAS UNABLE TO FOLLOW-UP WITH PHYSICIAN THAT PLACED THE ENDOTINE IMPLANT SINCE THIS PRODUCT WAS SHIPPED TO MULTIPLE PHYSICIANS/CUSTOMER ACCOUNTS WITHIN (B)(6) DURING 2018 AND 2019. BASED ON THE INFORMATION PROVIDED BY THE PATIENT ON THE SUBMITTED MEDWATCH FORM (MW5101159) IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. MICROAIRE WILL CLASSIFY THIS COMPLAINT AS A "BROKEN DEVICE" SINCE THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE FAILURE MODE BUT THIS COMPLAINT WILL BE RE-OPENED IF FURTHER INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT FILED A REPORT TO THE FDA (MEDWATCH MW5101159) WHICH STATED "ENDOTINE IMPLANT REMOVED; (B)(6) 2020 I HAD A LEFT ENDOSCOPIC BROW LIFT PROCEDURE. THE PROCEDURE WENT WELL. WITHIN A FEW WEEKS I FELT LIKE I HAD MOVEMENT AROUND THE SURGICAL SITE. MY PHYSICIAN'S OFFICE INDICATED THE ENDOTINE'S HAD COME UP FROM THEIR IMPLANTED POSITION, WHICH SOMETIMES OCCURRED, BUT THEY WOULD DISSOLVE. IN (B)(6) THE ENDOTINES WERE NOT DISSOLVED AND I MET WITH MY PHYSICIAN'S OFFICE AGAIN, AT THIS TIME, IT WAS DETERMINED THAT THEY NEEDED TO BE REMOVED AND AN APPOINTMENT WAS SCHEDULED. ON (B)(6) 2021 THE LARGEST PIECES OF ENDOTINE WHICH HAD BROKEN APART AND WERE IMBEDDED IN SCAR TISSUE WERE REMOVED. THE TWO FOLLOWING DAYS MY FACE AND NECK HAVE BEEN EXTREMELY SWOLLEN AND THERE HAS BEEN DISCHARGE FROM THE INCISION SITE. THERE IS ALSO A VERY TENDER SPOT IN MY NECK WHICH FEELS VERY SIMILAR TO THE ENDOTINES WHICH WERE IN MY SCALP. THE SWELLING IN MY FACE HAS RADIATED TO THE RIGHT SIDE OF MY FACE, BACK TO MY EAR AND NECK. MY PHYSICIAN IS HIGHLY SKILLED AND I BELIEVE THIS IS A FAILED ENDOTINE. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968879 CFD-22102 ENDOTINE FOREHEAD 3.5 HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-22102 324268

    Patients

    Seq Age Sex Outcome Treatment
    1