BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PROXIMATE PLUS MD SKIN STAPLER

    MDR report key: 250783 · Received November 18, 1999

    Report

    Report Number
    1527736-1999-05954
    Event Type
    Malfunction
    Date Received
    November 18, 1999
    Report Date
    October 23, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (1) PMW 35 WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE STAPLES DID NOT FORM PROPERLY. THE CASE WAS COMPLETED WITH A NEW DEVICE AND THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PROXIMATE PLUS MD SKIN STAPLER SKIN STAPLERS GDT ETHICON ENDO-SURGERY, INC. NA M4FE1E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other