BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE RECEIVING SHEET

    MDR report key: 2536415 · Received April 10, 2012

    Report

    Report Number
    3004635124-2012-00001
    Date Received
    April 10, 2012
    Date of Event
    March 1, 2012
    Report Date
    April 10, 2012
    Manufacturer
    GLOBAL HEALTHCARE
    Product Code
    KME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    GLOBAL HEALTHCARE (GHC) SUPPLIES BULK, NON-STERILE INFANT RECEIVING BLANKETS TO A CUSTOMER IN (B)(6). ON (B)(6) 2012, THE CUSTOMER, WHO IS A DISTRIBUTOR OF MEDICAL PRODUCTS ADVISED THAT AN END USER (HOSPITAL) HAD FOUND AND REPORTED UNITS IN CERTAIN LOTS OF THE PRODUCT "CONTAMINATED WITH BLACK SPOTS OR PARTICLES". IN A SUBSEQUENT COMMUNICATION DATED (B)(6), THE CUSTOMER ADVISED GHC THAT THE END USER HAD OBTAINED MICROBIOLOGICAL TESTING INDICATING THAT THE BLANKETS WERE CONTAMINATED WITH E-COLI". THE PRODUCT DID NOT COME INTO CONTACT WITH A PT AND THERE IS NO REPORT OF INJURY. UPON RECEIPT OF THE INITIAL NOTIFICATION GHC BEGAN AN INVESTIGATION. REQUESTS FOR SAMPLES OF THE PRODUCT ALLEGED TO BE CONTAMINATED HAVE BEEN MADE AND THE SAMPLES RECEIVED FOR EVAL AND TESTING. THE INVESTIGATION REMAINS ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE RECEIVING SHEET INFANT RECEIVING BLANKET KME GLOBAL HEALTHCARE 30-BY-B NONO45,47,51

    Patients

    Seq Age Sex Outcome Treatment
    1