BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL SURGEONS GLOVES

    MDR report key: 3896014 · Received May 15, 2014

    Report

    Report Number
    3004763499-2014-00010
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 4, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Product Code
    KGO
    PMA / PMN Number
    K071700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MOLNLYCKE HEALTH CARE WAS NOTIFIED OF AN EVENT INVOLVING A SURGICAL GLOVE IN (B)(6) 2014 AND ASSESSMENT MADE AT THE TIME OF NOTIFICATION ((B)(6) 2014). THE FOLLOWING IS THE DESCRIPTION OF THE EVENT. DURING AN OPEN-CHEST SURGICAL PROCEDURE ON (B)(6) 2014, THE TIP OF THE INDEX FINGER OF THE SURGICAL GLOVE SHEARED OFF (DISLODGED) AND WAS NOT ABLE TO BE FOUND. THE INCIDENT OCCURRED WHEN THE TREATING PHYSICIAN WAS INSERTING A CHEST TUBE IN THE PATIENT. CLINICAL STAFF WERE NOT ABLE TO CONFIRM IF THE SHEARED OFF PIECE REMAINED IN THE CHEST CAVITY. A COMPANY REPRESENTATIVE MADE SEVERAL ATTEMPTS TO FOLLOW-UP WITH TREATING PHYSICIAN (VIA CALLS, PAGER, EMAILS ETC), BUT RECEIVED NO RESPONSE. HOSPITAL STAFF STATED THAT UPON IMAGING THE PATIENT, THERE WAS NO INDICATION OF ANY FOREIGN OBJECT PRESENT INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290552 BIOGEL SURGEONS GLOVES SURGICAL GLOVE KGO MOLNLYCKE HEALTHCARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other