BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL

    MDR report key: 19375251 · Received May 22, 2024

    Report

    Report Number
    3004763499-2024-00006
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 22, 2024
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    KGO
    UDI-DI
    00733255118473
    PMA / PMN Number
    K050184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLOVES TORE DURING A CHEST TUBE INSERTION, LEAVING A FOREIGN BODY IN THE PATIENT. REPEATED, UNSUCCESSFUL ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. IT IS UNCLEAR IF THE PIECE WAS REMOVED FROM THE PATIENT AND IF A SECONDARY SURGERY WAS REQUIRED FOR THE RETRIEVAL. THEREFORE, DUE TO A LACK OF INFORMATION REGARDING THE PATIENT RESOLUTION, THIS COMPLAINT HAS BEEN REASSESSED AND CLASSIFIED AS A SERIOUS EVENT ASSOCIATED WITH USE OF A MOLNLYCKE PRODUCT AND IS CONSIDERED REPORTABLE TO THE US FDA. RECEIVED MEDWATCH REPORT MW5154424 15MAY2024 PROVIDING THE FOLLOWING DESCRIPTION. RETAINED FOREIGN BODY (GLOVE FRAGMENT LEFT IN THE PATIENT'S CHEST) OCCURRED DURING THE CHEST TUBE PLACEMENT IN THREE (3) DIFFERENT PATIENTS PERFORMED BY DIFFERENT PROVIDERS ON THREE SEPARATE DATES USING BIOGEL PL UL TRATOUCH GLOVES FROM DIFFERENT LOCATIONS/SOURCES WITHIN THE FACILITY (ALL LOT NUMBER'S ARE NOT KNOWN AT THIS TIME). THIS REPORT IS FOR PATIENT 2: 3004763499-2024-00005 - PATIENT 1 (MW 5154425); 3004763499-2024-00006 - PATIENT 2 (MW 5154424); 3004763499-2024-00007 - PATIENT 3 (MW 5154423) - NOT RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788998 BIOGEL BIOGEL PI ULTRATOUCH GLOVES KGO MOLNLYCKE HEALTH CARE 41170 23J4028 00733255118473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other