Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0014

2. Registrant Information.

Registrant Reference Number: 2017RB206

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

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

03-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-NOV-17

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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Extra Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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).

The pet owner applied Advantage II extra large dog on a 7 year 10 month old, 61.4 kg, male neutered Newfoundland dog.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Newfoundland

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.83

7. Weight (provide a range if necessary )

61.4

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Gagging

• General
  • Symptom - Death
  • Symptom - Abnormal behaviour
  • Specify - behavioural disorder

• Nervous and Muscular Systems
  • Symptom - Head shaking
  • Specify - Head shake

12. How long did the symptoms last?

Unknown / Inconnu

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 November 2, 2017 the pet owner sought veterinary attention for fleas and lameness in a 7 year 10 month old, 61.4 kg, male neutered Newfoundland dog. The dog was not seen by the veterinarian and an appointment was made, and the pet owner was dispensed Advantage II for extra large dogs. The pet owner applied the Advantage II to the dogs skin at approximately 4 pm, and in less than 30 minutes the dog started shaking its head, became ataxic, and was foaming at the mouth. The dog was also gagging. The pet owner started to drive the dog to an urgent care facility and the dog died in transit. A post mortem examination is pending. The dog had a medical history of 'knee dysplasia' according to the pet owner.

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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

N - Unlikely A behavioural response like reported shaking of head to the product sensation or to the product smell may occur. Gagging is an unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. Foaming at mouth is unspecific and may be associated with gagging. Ataxia is not expected with appropriate topical product use. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Death here is likely associated with other unrelated causes. Even though time to onset is short, considering known safety profile of product and fatal outcome, a product involvement is unlikely.