BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6217880 · Received January 3, 2017

    Report

    Report Number
    1820334-2017-00018
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Report Date
    April 27, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT/ DEVICE CODE: NO INFORMATION PROVIDED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K) K032426. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    PLEASE SEE UPDATED CORRECTED INFORMATION AND REMOVE PREVIOUS COMMENT: "ADDITIONAL LOT INFORMATION RECEIVED HAS BEEN ASSESSED. COMPLAINT SENT BACK TO INVESTIGATION FOR FURTHER REVIEW.".

    Additional Manufacturer Narrative · 1

    IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    IT IS ALLEGED, "THE [PATIENT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2004 AT (B)(6). " IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    IT IS ALLEGED THE [PATIENT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2004 AT (B)(6). ADDITIONAL LOT INFORMATION RECEIVED HAS BEEN ASSESSED. COMPLAINT SENT BACK TO INVESTIGATION FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED (B)(6) 2017: PATIENT ALLEGES IVC FILTER PLACED ON (B)(6) 2004. NO ATTEMPTS TO RETRIEVE. PATIENT CITES NO OUTCOMES TO THE DEVICE. PATIENT ALLEGES THEY ARE WORRIED ABOUT FUTURE POSSIBLE PROBLEMS WITH THE FILTER.

    Description of Event or Problem · 1

    IT IS ALLEGED, "THE [PATIENT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2004 AT (B)(6). " IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other