BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR

    MDR report key: 7074277 · Received December 1, 2017

    Report

    Report Number
    3006646024-2017-00024
    Event Type
    Death
    Date Received
    December 1, 2017
    Date of Event
    October 17, 2017
    Report Date
    November 10, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR 0202583149 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 29-NOV-17 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC PERCUTANEOUS GASTROSTOMY TUBE PLACEMENT ON AN (B)(6) PATIENT WITH HEMIPLEGIC APHASIA AND SWALLOWING DISORDER, AN INJURY OCCURRED TO THE LOWER THIRD OF THE PATIENT'S ESOPHAGUS AND A PNEUMOMEDIASTINUM WAS DETECTED. THE ESOPHAGUS INJURY WAS ALLEGED TO BE DUE TO INTRUSION BY THE COLLAR OF THE CATHETER GASTROSTOMY. THE PATIENT WAS TRANSFERRED TO (B)(6) FOR A SURGICAL REPAIR OF THE INJURY. THE PATIENT REPORTEDLY DIED FROM POSTOPERATIVE COMPLICATIONS. DATE OF DEATH IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855227 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR DH EF PEG INITIAL PLACEMENT PRODUCTS KNT HALYARD HEALTH 8644-20 0202583149

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R