BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOBBHOFF P.E.G.

    MDR report key: 185904 · Received September 2, 1998

    Report

    Report Number
    2242547-1998-00100
    Event Type
    Injury
    Date Received
    September 2, 1998
    Date of Event
    June 1, 1997
    Report Date
    September 2, 1998
    Manufacturer
    BIOSEARCH MEDICAL PRODUCT, INC.
    Product Code
    KNT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    BASED ON A LETTER DATED AUGUST 21, 1998 BY ATTORNEY BIOSEARCH MEDICAL PRODUCTS WAS INFORMED ABOUT THE INCIDENT ON JUNE, 1997 WHEN PT WAS CRITICALLY INJURED AT MEDICAL CENTER AFTER SEVERAL ATTEMPTS TO REMOVE THE PEG TUBE. THERE WAS A HOLE IN THE POSTERIOR ASPECT OF STOMACH WHICH REQUIRED MONTHS OF HOSPITALIZATION, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOBBHOFF P.E.G. Implant PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT KNT BIOSEARCH MEDICAL PRODUCT, INC. NA F-9013-3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R