BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 4129308 · Received September 18, 2014

    Report

    Report Number
    3003753847-2014-00017
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO. LTD.
    Product Code
    IME
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS THE PRIVATE-LABEL DISTRIBUTOR AND INITIAL IMPORTER OF THE 69902 PERINEAL COLD PACK, (B)(4) RECEIVED A REPORT FROM A HOSPITAL THAT A "PATIENT IN LABOR AND DELIVERY WAS GIVEN A PERI COLD PACK TO USE ON HER FOREHEAD. ACCORDING TO PATIENT'S MOTHER THE ICE PACK BURST AND THE CONTENTS OF THE PRODUCT GOT INTO THE PATIENT'S EYES AND HER NEWBORN'S EYES." THE HOSPITAL CONFIRMED THAT THE EYES OF BOTH THE PATIENT AND THE NEWBORN WERE FLUSHED WITH WATER BY THE NURSE AFTER THE INCIDENT TO PREVENT THE CONTENTS FROM CAUSING DAMAGE TO THE EYE. AFTER FOLLOW-UP WITH THE HOSPITAL, IT WAS REPORTED TO THE NURSE THAT THE PACK BURST AFTER 10 MINUTES OF USE ON THE PATIENT'S FOREHEAD. NO FURTHER ACTIONS TAKEN TO TREAT THE PATIENT WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580154 MEDICHOICE PERINEAL COLD PACK IME SHANGHAI INTCO MEDICAL SUPPLY CO. LTD. 69902 1401IC02A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention