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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2892

2. Registrant Information.

Registrant Reference Number: Prosar case 1-15070717

Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation

Address: 870 Technology Way

City: Libertyville

Prov / State: Illinois

Country: USA

Postal Code: 60048

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

03-JUL-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-JUL-07

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: VectoBac (non-specific)

  • Active Ingredient(s)
    • BACILLUS THURINGIENSIS VAR. ISRAELENSIS

7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shephard

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.91

7. Weight (provide a range if necessary )

90

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify No witnessed exposure. The bag of product was found open and the owner thought the dog may have ingested some product.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-15070717: The reporter called on 7/3/07 to report her 11 month old dog may have eaten some product containing the active ingredient Bacillus Thuringiensis subsp. israelensis. According to the reporter, about 12 hours prior to the call she had noticed an open bag of the product. Since then she had also noticed her dog had become lethargic and anorexic. The safety profile of the product was discussed, including the products ability to act as a GI irritant. A recommendation was made to monitor for vomiting/nausea/diarrhea, to replace any fluids lost if symptoms developed, and to seek veterinary care if symptoms persisted or worsened. A follow-up call revealed the dogs symptoms had lasted for 24 hours. The dog had not been taken to a veterinarian but a stool sample had been checked. The reporter had not heard back from the veterinarian regarding the stool sample and assumed that it had been negative. Note: The reporter identified the product from memory as the label on the bag had worn off.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here