BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6098776 · Received November 14, 2016

    Report

    Report Number
    1820334-2016-01283
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 16, 2016
    Report Date
    October 16, 2016
    Manufacturer
    COOK INC
    Product Code
    EYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: SINCE NO RPN, LOT NUMBER OR DEVICE SPECIFIC INFORMATION IS AVAILABLE, THE REVIEW OF THE EXACT SPECIFICATIONS, IFU, MANUFACTURING, QUALITY CONTROL DOCUMENTS, WORK ORDERS OR NON-CONFORMANCES COULD NOT BE PERFORMED AT THIS TIME. GIVEN THE NOTE "MULTIPURPOSE DRAIN- NEPH DRAIN" FROM THE INTERNAL NOTES OF THE COMPLAINT IT IS REASONABLE TO SUGGEST THE DEVICE FROM THE COMPLAINT MIGHT BE A MULTIPURPOSE DRAINAGE CATHETER WITH MACLOC. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS, AND THAT THE DEVICE MEETS THE NEEDS OF THE USER. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE HEALTH RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE PATIENT WAS IN CARE OF THE HOSPICE NURSE, THE DRAIN HUB SEPARATED FROM THE CATHETER. THE PATIENT WAS SENT TO THE HOSPITAL AND THE DRAIN WAS TAPED OFF UNTIL THE PROCEDURE FOR THE REPLACEMENT OF THE DEVICE COULD BE PERFORMED. AT THE TIME OF THIS REPORT NO OTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE PATIENT WAS IN CARE OF THE HOSPICE NURSE, THE DRAIN HUB SEPARATED FROM THE CATHETER. THE PATIENT WAS SENT TO THE HOSPITAL AND THE DRAIN WAS TAPED OFF UNTIL THE PROCEDURE FOR THE REPLACEMENT OF THE DEVICE COULD BE PERFORMED. AT THE TIME OF THIS REPORT NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749860 UNKNOWN EYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention