BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 3820680 · Received May 7, 2014

    Report

    Report Number
    1644019-2014-00080
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED FOR EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO HAS BEEN REQUESTED FOR THIS DATE, HOWEVER NONE HAS BEEN PROVIDED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT THE MAYO COVERS AND THE STUFF THAT THEIR GOWNS ARE WRAPPED IN IS VERY "LINTY". SHE ALSO NOTED THAT THEY HAVE HAD THREE EYE INFECTIONS IN THE LAST EIGHT MONTHS SINCE THIS ISSUE WITH LINT STARTED. THE CUSTOMER DID NOT KNOW IF THE LINT WAS DIRECTLY RELATED TO THE INFECTIONS OR NOT. ADD'L INFO HAS BEEN REQUESTED, HOWEVER, NONE HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276673 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other