BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAI STERILE LAP SPONGE/VHA+PLUS

    MDR report key: 12127 · Received February 22, 1994

    Report

    Report Number
    12127
    Event Type
    Injury
    Date Received
    February 22, 1994
    Date of Event
    July 28, 1993
    Report Date
    October 18, 1993
    Manufacturer
    MAI
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT READMITTED 9/9/93 WITH HEMIARTHROSIS RIGHT KNEE, STATUS POST SUCCESSFUL RIGHT TOTAL KNEE ARTHROPLASTY ON 7/28/93. TAKEN TO OR 9/12/93 FOR I & D. NO SIGNS OF INFECTION AT SURGERY. MULTIPLE CULTURES OBTAINED; NO GROWTH (NO FUNGAL CULTURES DONE). PT DEMONSTRATED GENERALIZED COAGULOPATHY; ETIOLOGY UNCLEAR AT TIME OF SURGERY. ON 9/14/93, PT CONSIDERED TOXIC WITH NO SPECIFIC FOCUS OF INFECTION (WITH ANTBX COVERAGE). COAGULOPATHY IMPROVED UNTIL 9/16/93; PT THEN DETERIORATED; BLEEDING FROM DRAIN AND REQUIRING BLOOD COMPONENT REPLACEMENT. DIAGNOSED WITH DIC. PT TRANSFERRED TO ANOTHER HOSP 9/18/93; AKA DONE THERE. REFERRED TO FDA BECAUSE OF POSSIBLE CONTAMINATION FROM LAP SPONGES DURING JULY SURGERY PRIOR TO RECALL NOTICE OF 9/8/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAI STERILE LAP SPONGE/VHA+PLUS LAP SPONGES GDY MAI NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Not Applicable| H ZIMMER MG II POROUS TOTAL KNEE SYSTEM