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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6369

2. Registrant Information.

Registrant Reference Number: 2013CK036

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.

Unknown

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. Unknown

Product Name: Advantage II (unspecified)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 an unknown date in 2012, a 10 year old, male, canine of unknown signalment, in unknown condition, with no known concurrent medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) 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

Dog / Chien

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Eye
    • Symptom - Blindness (permanent)
  • General
    • Symptom - Neoplasia

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 an unknown date post application the dog exhibited blindness, tumor of unknown origin and death. Diagnostics and treatments are unknown. No necropsy was performed. No more information is expected. The owner initially contacted Bayer Animal Health to seek advise on how to control an active flea infestation and 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 dog was casually provided during an inquiry. The level of information is very low (no application date, no time to onset, missing info on patient and product details). Nevertheless blindness, tumor of unknown origin and death are inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20- fold overdosage tolerated by dogs without showing any side effect. The cause of death of this geriatric dog was probably due to underlying cause of tumor according to case description. Product was used on animal before unknowing causing signs. Finally, a product relation can be completely excluded.