BEUDAMED
    FDA Adverse Event Summary report: N

    BIG PACK

    MDR report key: 16788 · Received October 13, 1994

    Report

    Report Number
    MW1003667
    Date Received
    October 13, 1994
    Report Date
    October 12, 1994
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GAO
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AROUND 9/10/94, ANOTHER MFR'S REP CAME TO THE HOSP AND INFORMED THE HOSP THAT THE COMPANY WAS VOLUNTARILY RECALLING SOME SUTURES. THE RPTR STATED THAT THE REP MADE IT SOUND LIKE "NO BIG DEAL" AND PULLED ALL THE SUTURES THAT WERE AFFECTED. THE REP WOULD NOT PUT ANYTHING IN WRITING. THE RPTR HEARD NOTHING MORE UNTIL SHE RECEIVED A FAX FROM MFR ON 10/5/94, STATING THAT THE SUTURES IN 4 SPECIALLY-MADE PACKS THE HOSP USED, CONTAINED THE RECALLED SUTURES. ON 10/5/94, THE RPTR CALLED THE OTHER MFR TO INQUIRE ABOUT THE RECALL. SHE WAS FAXED THE PRODUCT NUMBERS OF THE RECALLED SUTURES WHICH TOTALED FOUR PAGES CONTAINING TWO COLUMNS EACH. THE RPTR IS CONCERNED THAT SHE NEVER RECEIVED ANYTHING IN WRITING FROM THE OTHER MFR AND ONLY RECENTLY WAS INFORMED BY THE PACK MFR THAT THE RECALLED SUTURES WERE ON THE TRAYS USED AT THE HOSP. (ALSO SEE 1003667).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIG PACK GAO BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *