BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAP SPONGES

    MDR report key: 1603374 · Received January 28, 2010

    Report

    Report Number
    2083545-2010-00001
    Event Type
    Other
    Date Received
    January 28, 2010
    Date of Event
    August 3, 2009
    Report Date
    December 3, 2009
    Manufacturer
    A PLUS INTERNATIONAL, INC
    Product Code
    GDY
    PMA / PMN Number
    K881395
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNED SAMPLE FROM THE (B)(6) HOSPITAL OF (B)(6) WAS AVAILABLE IN CONNECTION TO THE MEDWATCH REPORT. SOME STERILE LAP SPONGE PACK SAMPLES FROM THE SAME LOT NUMBER WERE RETURNED BY THE (B)(6) HOSPITAL RECENTLY. HOWEVER, WE CANNOT BE SURE THAT THE SAMPLES WERE RELATED TO THE RECENT MEDWATCH REPORT. SAMPLES FROM LOT NUMBER 7408 PREVIOUSLY RETURNED FROM THE (B)(6) HOSPITAL WERE CAREFULLY EXAMINED. NO LINT OR LOOSE ATTACHED THREAD THAT MIGHT BE DESCRIBED AS "LINT" WAS FOUND IN THE RETURNED UNOPENED PACKAGES OF THE STERILE LAP SPONGES. SOME PACKAGES WERE ALSO OPENED TO CHECK THE LAP SPONGES, NO NONCONFORMING CONDITION WAS DISCOVERED. WE ALSO CHECKED THE PRODUCTION AND QUALITY RECORDS (INCLUDING THE USP GAUZE MONOGRAPH TEST RESULTS) FOR THE LOT NUMBER IN QUESTION, AND NO NONCONFORMING CONDITION WAS FOUND. WE ALSO CHECKED THE CUSTOMER COMPLAINT TRENDING RECORDS, AND NO OTHER SIMILAR COMPLAINT WAS REPORTED BY OTHER CUSTOMERS ON THIS LOT NUMBER OF LAP SPONGES. (B)(4). HOWEVER, THIS DOES NOT AFFECT THE SAFETY AND INTENDED USE OF THE PRODUCTS.

    Description of Event or Problem · 1

    EVENT DESC: UNOPENED PACKAGES OF STERILE LAP SPONGES CONTAIN LINT. DEVICE USAGE PROBLEM: OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP SPONGES GDY A PLUS INTERNATIONAL, INC 7408

    Patients

    Seq Age Sex Outcome Treatment
    1 Other