BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP SPONGES = MEDICAL ACTION (ACQUIRED BY OWENS & MINOR)

    MDR report key: 4859414 · Received June 16, 2015

    Report

    Report Number
    MW5043170
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MEDICAL ACTION OWENS & MINOR
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTREMITY PACK CATALOG# 622279, LOT# 1178746 REV 15 CONTAMINANTS IN LAP SPONGES. THE LAP SPONGES FOUND IN THE PHS PACKS ARE MADE BY MEDICAL ACTION. VENDOR ITEM #(B)(4). DESCRIPTION: SPONGE, LAP 18X18 PRE-WASHED. WAREHOUSING:(B)(4). MAXILLOFACIAL PACK CATALOG# 660040, LOT#: 1182285 REV 14. BLACK SPECKS ON RAYTEC GAUZE. PHS PACKS= (B)(4). SAME REPORTER IN MW5043161- MW5043178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392719 LAP SPONGES = MEDICAL ACTION (ACQUIRED BY OWENS & MINOR) LAP SPONGE GDY MEDICAL ACTION OWENS & MINOR
    392720 RAYTEC GAUZE = COVIDIEN/ KENDALL GAUZE GDY COVIDIEN - KENDALL

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTREMITY PACK 622279, LOT# 1178746| MAXILLO FACIAL PACK 660040, LOT# 1182285