BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCOOL SURGICAL GOWN

    MDR report key: 865785 · Received June 13, 2007

    Report

    Report Number
    8044184-2007-00074
    Event Type
    Other
    Date Received
    June 13, 2007
    Date of Event
    May 2, 2007
    Report Date
    June 13, 2007
    Manufacturer
    KIMBERLY CLARK CORP
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPRESENTATIVE SAMPLE FROM PROD IN POSSESSION OF THE HOSP IS BEING RETURNED FOR EXAMINATION. AS REQUIRED A MDR F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON MAY 7, 2007, A REPORT WAS REC'D THAT A PHYSICIAN REPORTED A REACTION TO A MICROCOOL GOWN, PROD CODE 92039. INCIDENT OCCURRED IN 2007 AT CHILDREN'S HOSP. THIS WAS THE FIRST TIME THE MICROCOOL GOWN WAS BEING WORN BY THIS PHYSICIAN. INITIALLY THE PHYSICIAN NOTED THE SLEEVES ON THE LOWER HALF OF THE GOWN WERE ROUGH. THIRTY MINS AFTER DONNING THE GOWN, HE NOTED IRRITATION TO BOTH ARMS, SEVERE ENOUGH TO CAUSE HIM TO LEAVE THE OR AND ASK ANOTHER PHYSICIAN TO STEP IN FOR SURGERY. HE IMMEDIATELY REMOVED THE GOWN AND NOTED REDNESS AND A RASH ON BOTH WRISTS AND FOREARMS EXTENDING TO THE ELBOWS. HE DID NOT SEEK MEDICAL ATTN, AND THE RASH RESOLVED ON ITS OWN AFTER 24 HRS. WHILE THE RASH WAS PRESENT, THE PHYSICIAN WAS UNABLE TO PERFORM SURGERIES. KIMBERLY-CLARK HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING THE INFO REC'D FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCOOL SURGICAL GOWN SURGICAL GOWN FYA KIMBERLY CLARK CORP NA 7007421

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other