BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 14496545 · Received May 25, 2022

    Report

    Report Number
    1018233-2022-04093
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 9, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE COMB WAS DAMAGED. THE COMB WAS REPLACED AND RESOLVED THE REPORTED ISSUE. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEG BAG VELCRO STRAPS WERE UNCOMFORTABLE (PCN-150719 AND PCN-150732), AND THE LEG BAGS WOULD STICK TO THE SKIN WHICH CAUSED PAIN WHEN STANDING UP AND DOWN PCN-150719 AND PCN-150732). ALSO STATED THAT THERE WAS AN IRRITATION IN THE URINARY TRACT FROM THIS ISSUE AND THIS COULD CAUSE INFECTION (PCN-(B)(4) AND PCN-(B)(4)). NO MEDICAL INTERVENTION WAS REPORTED.AS PER THE FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT PUTS A CLOTH BETWEEN THEIR LEG BAG AND SKIN TO HELP PREVENT IRRITATION AND THE VELCRO STRAPS WERE TOO HARD SHARP THAT IRRITATES ALSO. IT WAS ALSO STATED THAT THE PATIENT RECENTLY HAD A URINARY TRACT INFECTION AND WAS PRESCRIBED WITH ANTIBIOTICS FROM THEIR DOCTOR . CUSTOMER PREFERRED INFECTION CONTROL FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754378 LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention