BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGEL PI ULTRA TOUCH GLOVES

    MDR report key: 6031983 · Received October 15, 2016

    Report

    Report Number
    3004763499-2016-00003
    Event Type
    Injury
    Date Received
    October 15, 2016
    Date of Event
    February 19, 2016
    Report Date
    February 19, 2016
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    KGO
    PMA / PMN Number
    K050184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVIATIONS WERE IDENTIFIED IN THE BATCH DOCUMENTATION. VISUAL EXAMINATION OF RETAINED SAMPLE WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT A PIECE OF GLOVE TORE OFF INSIDE OF PATIENT DURING SURGICAL PROCEDURE AND COULD NOT BE LOCATED. A PICTURE OF THE BOX THE COMPLAINT GLOVE CAME FROM WAS PROVIDED. THE HOSPITAL REPORTED THEY RETAINED THE ACTUAL COMPLAINT GLOVE. REQUEST WAS MADE TO PROVIDE A PICTURE OF THE ACTUAL GLOVE AND ADDITIONAL INFORMATION REGARDING THE EVENT. ON (B)(6) 2016, ADDITIONAL INFORMATION WAS RECEIVED. THE EVENT OCCURRED IN ASSOCIATION WITH A SHOULDER ARTHROSCOPY. THE SURGEON WAS DOUBLE GLOVED. THE UNDERGLOVE WAS NOT PERFORATED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE. IN AN EFFORT TO LOCATE THE TORN PIECE OF GLOVE, IRRIGATION, X-RAY, ENDOSCOPE AND CAT SCAN WERE PERFORMED. THE MISSING PIECE WAS APPROX 2MM X 6MM AND WAS FIRST NOTICED AS SOON AS THE FINGER WAS REMOVED FROM THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683177 BIOGEL PI ULTRA TOUCH GLOVES SURGICAL GLOVE KGO MOLNLYCKE HEALTH CARE 41175 15I187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other