BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    CARDINAL HEALTH

    MDR report key: 15787618 · Received November 14, 2022

    Report

    Report Number
    15787618
    Event Type
    No answer provided
    Date Received
    November 14, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 7, 2022
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A MINOR HEAD AND NECK PACK WAS USED FOR THE SETUP OF A PAROTIDECTOMY. ONE SET OF RAYTEC SPONGES IS SUPPOSED TO COME WITH THIS PACK. WHILE PERFORMING THE INITIAL COUNT WITH THE CIRCULATING NURSE, THE SCRUB NURSE COUNTED 9 RAYTECS (RATHER THAN A COMPLETE SET OF 10). THE COUNTS WERE PERFORMED AGAIN TO VERIFY THAT A FULL SET OF RAYTEC SPONGES HAD NOT COME WITH THE PACK. PACK REF# SEN7CHNYNM, PACK LOT# 873770. MANUFACTURER RESPONSE FOR SPONGE PACK, HEAD AND NECK PACK (PER SITE REPORTER) INFORMED REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830150 CARDINAL HEALTH GENERAL SURGERY TRAY LRO CARDINAL HEALTH 200, LLC SEN7CHNYNM 873770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown