BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE 8X4 DUAL XRAY 10'S

    MDR report key: 1589337 · Received January 25, 2010

    Report

    Report Number
    1047429-2010-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Report Date
    January 7, 2010
    Manufacturer
    WELMED INC.
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATERIALS DIRECTOR OF (B)(6) SURGERY CTR CONTACTED AVID MEDICAL'S SALES REP ON (B)(6)2010 STATING THAT ONE OF HIS DOCTORS WAS UPSET BECAUSE OF A PT HAD DEVELOPED AN INFECTION AFTER SURGERY AND UPON FURTHER INSPECTION IT WAS DETERMINED THAT THE CAUSE OF INFECTION WAS 'GAUZE FIBERS' LEFT IN THE SURGICAL AREA FROM THE X-RAY GAUZE WHICH WAS IN AVID'S CUSTOM PROCEDURE TRAY. THE SALES REP ASKED FOR FURTHER INFO AND ON 01/12/2010 RECEIVED THE AVID LOT# 614242 CATALOG # ABSC002-03 HAND PACK. IT WAS DETERMINED THAT THE GAUZE WAS OUR PART # 521680 GAUZE, 8X4, DUAL X-RAY, 10'S PURCHASED FROM WELMED INC. VENDOR ITEM # 10-8416-7 LOT # 08-1321-1. AVID ASSIGNED COMPLAINT # (B)(4) AND HAS ALSO SUBMITTED A FORMAL COMPLAINT TO WELMED INC. AVID HAS RECEIVED NO OTHER REPORTS OF INJURY DUE TO THE COMPLAINED GAUZE. AVID SENT REPLACEMENT STERILE GAUZE FROM A DIFFERENT MFR TO (B)(6) SURGERY CENTER.

    Description of Event or Problem · 1

    THE MATERIALS DIRECTOR OF SURGERY CENTER CONTACTED OUR SALES REP ON (B)(6) 2010 STATING THAT ONE OF HIS DOCTORS WAS UPSET BECAUSE A PT HAD DEVELOPED AN INFECTION AFTER SURGERY AND UPON FURTHER INSPECTION IT WAS DETERMINED THAT THE CAUSE OF INFECTION WAS 'GAUZE FIBERS' LEFT IN THE SURGICAL AREA FROM THE X-RAY GAUZE. THE SURGERY CENTER HAS DISCONTINUED USE OF THIS GAUZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAUZE 8X4 DUAL XRAY 10'S GDY GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY WELMED INC. 10-8416-7 08-1321-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other