BEUDAMED
    FDA Adverse Event Summary report: N

    NATURAL IMAGE ULTRASOUND SCANNING GEL

    MDR report key: 11676 · Received February 22, 1994

    Report

    Report Number
    MW4000306
    Date Received
    February 22, 1994
    Report Date
    June 3, 1993
    Manufacturer
    ACCUPAC, INC.
    Product Code
    KNG
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED INFO UNCOVERED DURING A CIVIL TRIAL ON 5/12/93 WHERE MFR TESTIFIED UNDER OATH THAT THEY WERE IN VIOLATION OF FDA GMP IN HAVING "LOST" AND NOT REPLACED FROM THEIR CUSTOMER COMPLAINT FILE REPORTS OF MOLD CONTAMINATION OF MEDICAL DIAGNOSTIC ULTRASOUND SCANNING GELS WHICH MFR HAD MFG FOR ANOTHER CO. MFR ALSO TESTIFIED UNDER OATH TO NOT HAVING NOTIFIED THE FDA OF THE MISSING DOCUMENTS DURING FDA INSPECTIONS OF FACILITY, TO HAVING "LOST" LAB RECORDS OF THE CONTAMINATED PRODUCT, AND TO HAVING "LOST" THE ACTUAL SAMPLE OF THE CONTAMINATED PRODUCT SUPPLIED TO MFR BY THE CO THAT GEL IS MFG FOR. WHEN THEY OPENED THE 40 GALLON FIBER DRUMS OF THE ULTRASOUND SCANNING GEL, THE SURFACE WAS COVERED WITH MOLD. APPROX 10 TO 20% OF THE 800 8 OZ PLASTIC BOTTLES OF PRODUCT HAD MOLD AT THE TOP. PRODUCT WAS IMMEDIATELY QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL IMAGE ULTRASOUND SCANNING GEL KNG ACCUPAC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *