BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6757557 · Received August 1, 2017

    Report

    Report Number
    1820334-2017-01904
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    May 26, 2017
    Report Date
    November 9, 2017
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION : A REVIEW OF QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE COMPLAINT LOT NUMBER WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION, NO PRODUCT RETURNED AND THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BY USER FACILITY MEDWATCH AND FDA REPORT NUMBER MW5070732 THAT A "PATIENT HAD GASTROSTOMY TUBE PLACED ON (B)(6) 2013 S/P GASTRIC BYPASS SURGERY. SHE HAD A KUB [X-RAY VIEW SHOWING KIDNEY, URETER, AND BLADDER] IN (B)(6) 2017 FOR C/O ABDOMINAL PAIN AND THE IMAGES SHOWED A RETAINED FOREIGN OBJECT. SHE UNDERWENT SURGERY ON (B)(6) 2017 FOR REMOVAL OF WHAT APPEARED TO BE A GASTROPEXY T-TRACK (PLACED IN 2013) THAT HAD MIGRATED AND EMBEDDED INTO ABDOMINAL WALL." THE INFORMATION PROVIDED INDICATES A PRODUCT BRAND NAME OF "T-TACK GASTROINTESTINAL TUBE AND ACCESSORIES." THE FDA PROCODE REPORTED IS: "KNT - TUBES, GASTROINTESTINAL AND ACCESSORIES." COOK SUTURE ANCHORS ARE SUPPLIED WITH CATHETERS MANUFACTURED BY (B)(4) UNDER THE FDA PROCODE OF KNT, ALTHOUGH NO CONFIRMATION OF THE DEVICE MANUFACTURER HAS BEEN POSITIVELY ASCERTAINED AT THIS TIME. ADDITIONAL INFORMATION TO CLARIFY THE SPECIFIC CATHETER AND /OR ANCHORING DEVICE USED ON THIS PATIENT WAS REQUESTED FROM THE INITIAL REPORTER; NO UPDATE INFORMATION WAS RECEIVED AS OF THE DATE OF THIS REPORT. COOK WILL CONTINUE TO INVESTIGATE THIS EVENT TO DETERMINE IF THE DEVICE IS ONE MANUFACTURED BY (B)(4) OR THAT OF ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538631 UNKNOWN FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR