BEUDAMED
    FDA Adverse Event Summary report: N

    LATEX SURGEON'S GLOVE

    MDR report key: 3161916 · Received May 15, 2013

    Report

    Report Number
    1417592-2013-00034
    Date Received
    May 15, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A SURGEON LOST A GLOVE TIP DURING SURGERY. THE TIP WAS RECOVERED OUTSIDE OF THE PT. THERE WAS NO INJURY OR NEED FOR FURTHER INTERVENTION. THE CONTACT AT THE FACILITY STATED THAT THE INCIDENT MAY HAVE OCCURRED WHILE THE SURGEON WAS SUTURING. THE SAMPLE WAS RETURNED AND EVALUATED. NO MFG DEFECT WAS IDENTIFIED. A ROOT CAUSE WAS NOT DETERMINED BUT WE CANNOT RULE OUT USER ERROR AS A CONTRIBUTING FACTOR TO THE TEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON LOST A GLOVE TIP. IT WAS RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215889 LATEX SURGEON'S GLOVE KGO MEDLINE INDUSTRIES, INC. 2012-352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other