BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOVE TRIFLEX 6.5 PWD LATEX SURGEON

    MDR report key: 1616823 · Received February 5, 2010

    Report

    Report Number
    1423507-2010-00009
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    June 29, 2009
    Report Date
    February 4, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO THE UNAVAILABILITY OF THE LOT NUMBER. HISTORICAL TRENDING WAS DONE. THE SAMPLE WAS UNAVAILABLE TO BE RETURNED FOR PHYSICAL TESTING. THE TRIFLEX GLOVE HAS PASSED A SERIES OF TESTS PRESCRIBED BY REGULATORY AGENCIES FOR THE INTENDED USE OF THE GLOVE. HOWEVER, THE POSSIBILITY OF SOME INDIVIDUALS EXPERIENCING REACTIONS CANNOT BE RULED OUT. POST-OP TESTING SHOWED THIS PT HAD A LATEX ALLERGY. CATALOG NUMBER REPORTED 2D7252J, SIMILAR PRODUCT SOLD IN THE US (CATALOG NUMBER 2D7252). AS ALREADY MENTIONED, THE DETAILED ANALYSIS COULD NOT BE CARRIED OUT DUE TO WHICH WE COULD NOT DETERMINE THE ROOT CAUSE OF THE REPORTED DEFECT AND INITIATE ANY CORRECTIVE ACTION.

    Description of Event or Problem · 1

    INCIDENT OCCURRED IN (B)(6). A GYNECOLOGIST DID NOT FIND ANY ALLERGIC REACTION ON A PT WHEN HE PALPATED BEFORE THE SURGERY AND PLACED A CATHETER FOR EPIDURAL ANESTHESIA. EVEN AFTER SURGERY BEGAN, UNTIL THE SKIN INCISION, HE DID NOT DETECT ANY SYMPTOM. AS HE WAS STARTING THE INCISION OF THE PERITONEUM, THE PT WENT INTO SHOCK (VITAL SIGNS WERE NOT NORMAL, AND THE BLOOD PRESSURE WENT DOWN TO 45/18). THE DOCTOR ADMINISTERED A VASOPRESSOR WHICH STABILIZED THE PT'S CONDITION. A PATCH TEST WAS CONDUCTED AFTER THE SURGERY, AND THE RESULT SHOWED THAT THE PT WAS ALLERGIC TO LATEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE TRIFLEX 6.5 PWD LATEX SURGEON POWERED LATEX SURGEON GLOVE KGO CARDINAL HEALTH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other