BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL FOLEY SWIVEL SILICONE TRICOT 25BX

    MDR report key: 11838197 · Received May 17, 2021

    Report

    Report Number
    1018233-2021-02866
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EYJ
    UDI-DI
    00801741076114
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, BD HAS DETERMINED THAT THIS MDR EVENT IS NOT REPORTABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STATLOCK ARRIVED LARGER IN SIZE AND IT WAS MADE OF A DIFFERENT MATERIAL. USUALLY IT WAS MADE OF PLASTICS BUT THIS ONE HAD FABRIC. PER CUSTOMER VIA PHONE ON 14JUN2021, CUSTOMER STATED THAT COMPLAINT WAS FALSE AND THAT THERE WAS NO COMPLAINT. THE PACKAGING WAS DIFFERENT SO CUSTOMER ASSUMED WHAT WAS INSIDE THE PACKAGE WAS DIFFERENT BUT THAT WAS NOT TRUE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STATLOCK ARRIVED LARGER IN SIZE AND IT WAS MADE OF A DIFFERENT MATERIAL. USUALLY IT WAS MADE OF PLASTICS BUT THIS ONE HAD FABRIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731917 SL FOLEY SWIVEL SILICONE TRICOT 25BX STATLOCK DEVICE EYJ C.R. BARD, INC. (COVINGTON) -1018233 FOL0102 JUEZ0654 00801741076114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other