BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 4178963 · Received October 16, 2014

    Report

    Report Number
    1226348-2014-12053
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 30, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT IS MANUALLY PLACED IN A SEALER. THE OPERATION IS PERFORMED IN AN ISO CLASS 8 CLEANROOM. THE REQUIREMENTS FOR THIS ENVIRONMENT INCLUDE A HAIR-NET AND GOWN WITH LONG SLEEVES. THE HAIR CONTAMINATING THE PRODUCT APPEARS TO BE THE TYPE WHICH WOULD BE CONTAINED BY THE HAIRNET. THE COMPLAINT WAS REVIEWED WITH THE RESPONSIBLE OPERATORS TO RAISE AWARENESS OF THE ISSUE AND TO GATHER ANY IDEAS FOR IMPROVEMENT. (B)(4). BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: IT WAS FOUND A HUMAN HAIR INSIDE THE STERILE PACKAGE (BEFORE USED ON PATIENT). ACTION USER TOOK TO MITIGATE/ RESOLVE PROBLEM DURING PROCEDURE: WITH SAME LIKE PRODUCT. DID THE EVENT OCCUR DURING A PROCEDURE/SURGERY? NO,PRE OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657492 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF 469304

    Patients

    Seq Age Sex Outcome Treatment
    1