BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYTOLYT SOLUTION ASSEMBLY (NON-GYN)

    MDR report key: 906461 · Received August 29, 2007

    Report

    Report Number
    1222780-2007-00019
    Event Type
    Other
    Date Received
    August 29, 2007
    Date of Event
    July 31, 2007
    Report Date
    August 29, 2007
    Manufacturer
    CYTYC CORP.
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    CYTYC TECHNICAL SERVICE RECEIVED A CALL FROM REP. SHE STATED THAT FACILITY WAS CALLED BY A DOCTOR'S OFFICE WHO REPORTED, THAT A PT HAD INGESTED A CYTOLYT SOLUTION VIAL. TECHNICAL SERVICE INSTRUCTED RE[ AS TO WHERE TO LOCATE THE MSDS TO FAX TO THE DOCTOR'S OFFICE AND ALSO SUGGESTED THAT THE PT BE SENT TO THE EMERGENCY ROOM FOR FOLLOW-UP. FACILITY REPEATEDLY ATTEMPTED TO CONTACT THE DOCTOR'S OFFICE, BUT HAS NOT BEEN ABLE TO FOLLOW UP ON THE PT. IT IS UNK AT THIS TIME WHETHER THE PT RECEIVED MEDICAL TREATMENT OR THE STATUS OF THE PT. IF CYTYC BECOMES AWARE OF ANY ADD'L INFO, IT WILL BE SUBMITTED VIA A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTOLYT SOLUTION ASSEMBLY (NON-GYN) REAGENT/BUFFER FOR CYTOLOGY SLIDE PREP. LEA CYTYC CORP. 0236041 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other