BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PROXIMATE PLUS MD SKIN STAPLER

    MDR report key: 176909 · Received July 10, 1998

    Report

    Report Number
    1527736-1998-01975
    Event Type
    Malfunction
    Date Received
    July 10, 1998
    Report Date
    June 15, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED THE WOUND CLOSED WITH THE PMW 35 SKIN STAPLER DEHISCED POST-OP. IT IS UNK HOW THE CASE WAS COMPLETED. THE REP IS FOLLOWING UP FOR MORE INFO.

    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. S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other