BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 70156 · Received February 21, 1997

    Report

    Report Number
    1915484-1997-00002
    Event Type
    Injury
    Date Received
    February 21, 1997
    Date of Event
    November 28, 1996
    Manufacturer
    *
    Product Code
    KYX
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR COMPLAINT #NF1997-1-22-174. NO SAMPLES WERE RECEIVED FROM THE CUSTOMER. PRODUCT FROM DISTRIBUTION WAS EVALUATED. LABELING WAS EVALUATED. QUESTIONNAIRE RETURNED BY THE HOSPITAL STATED THEY ISSUED INSTRUCTIONS ON THE USE OF THE MEDICATION AND CARE OF THE INFANT. THEY DID NOT KNOW IF INSTRUCTIONS WERE GIVEN TO THE END USER CONCERNING THE USE OF THE SYRINGE, SPECIFICALLY REMOVING THE END CAP PRIOR TO ADMINISTERING MEDICATION TO THE INFANT. THE HOSPITAL REPORTS THEY HAVE NEVER HAD A SIMILAR INCIDENT REPORTED. A SEARCH OF CO'S FILES FINDS NO OTHER INCIDENTS REPORTED OVER THE LAST THREE YEARS. BASED UPON CO'S FINDINGS, THIS APPEARS TO BE AN ISOLATED EVENT INVOLVING USER ERROR. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KYX *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Hospitalization| L