Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1731

2. Registrant Information.

Registrant Reference Number: 2014CK81

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.

17-APR-14

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-127

Product Name: Advantage 55

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 Jun-2012, a 13 year old, 47.00 pounds, neutered male, Chowchow canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage Multi for Dogs 55 (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) 2.5 mL once topically by the owner.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

chow chow

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

47

lbs

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

• Ear
  • Symptom - Hearing loss

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

An unspecified time after product administration the dog developed hearing loss. The product was applied on a monthly basis until approximately Dec 2012 at which time the dog was switched to Advantage 55 Topical Solution (imidacloprid). After application of Advantage 55 the dogs' hearing returned,On an unknown date in Feb 2013 the dog was found in the yard deceased. No necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Reporting of occurrence more than one year after product application, occurrence of fatal outcome with two months not within close time of product application. Nevertheless returning of deafness after switching products and death are inconsistent with pharmaco-toxicological product profile and experience. Unknown exact time to onset after exposure of returning deafness. Death occured after approximately two months of exposure therefore time to onset too long. 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 is not further specified according to case description but is probably due to underlying causes of old age. Finally, a product relation can be excluded.