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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6263

2. Registrant Information.

Registrant Reference Number: 2013CK011

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Domestic Animal

4. Date registrant was first informed of the incident.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

30-SEP-09

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: Advantage 18

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

Units: mL

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

Site: Animal / Usage sur un animal domestique

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

On approximately 01-Sep-2009, a 17 year old, 12 pound, spayed, female, Domestic Shorthair feline, in poor condition, with a known medical history of an unknown cancer, was administered 1 tube of Advantage 18 Topical Solution (Imidacloprid) once topically by the owner.

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

Cat / Chat

3. Breed

Domestic short hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

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 - Death

12. How long did the symptoms last?

Persisted until death

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

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

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

On approximately 01-Sep-2009, a 17 year old, 12 pound, spayed, female, Domestic Shorthair feline, in poor condition, with a known medical history of an unknown cancer, was administered 1 tube of Advantage 18 Topical Solution (Imidacloprid) once topically by the owner. This cat was receiving an unknown regimen of chemo therapy prior to death as well. It is unknown when the last chemo therapy treatment was preformed. On approximately 30-Sep-2009 the cat passed away at home. The cat was not examined or treated by a veterinarian. No necropsy was preformed. The owner original contacted Bayer Animal Health to discuss expiration dates of current product on hand, not to report the death of this pet.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The information regarding the death of the cat was casually provided during an inquiry. Reporting of occurrence 4 years after product application. Nevertheless cancer resulting in death is not expected as inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24- fold overdosage tolerated by cats without showing any side effect. Death occured one month after last product exposure, therefore inconsistent chronology. The cause of death of this geriatric cat is probably due to the underlying disease (cancer) according to case description. No reaction on previous exposure. Finally, a product relation can be completely excluded.