BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULK SURG PAT 1 X 3

    MDR report key: 3823765 · Received May 21, 2014

    Report

    Report Number
    1226348-2014-11617
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    September 18, 2013
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: ONE PACK OF NEURO SPONGES CONTAINED 9 INSTEAD OF 10. NO INJURY REPORTED. NO SAMPLE AVAILABLE, NO EVENT DATE PROVIDED; THEREFORE, THE ALERT DATE WAS USED AS THE EVENT DATE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301552 BULK SURG PAT 1 X 3 COTTONOID, PADDIE HBA CODMAN & SHURTLEFF 377498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention