BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 19657436 · Received July 2, 2024

    Report

    Report Number
    2936999-2024-01020
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 8, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    JOH
    UDI-DI
    20884521779737
    PMA / PMN Number
    K182861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANT PRODUCT: 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#23H1402JZX 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#23I0523JZX 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#23I0523JZX 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#23I0523JZX 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN 5.5PCF - 5.5PCF 5.5MM ID PAED LGE CUFFED X1 - LOT#UNKNOWN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE REPORTED TRACHEOSTOMY TUBES HAD DIMENSIONAL ISSUES. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601948 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH MMJ SA DE CV (USD) 5.5PCF 20884521779737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose SEE H11.