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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4737

2. Registrant Information.

Registrant Reference Number: 2018TH046

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.

05-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

02-JUN-18

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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II extra large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

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).

On approximately 05-May-2018, a 2 year old, 110 pound, neutered, male, Retriever - Labrador/Poodle - Standard crossbred dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II via the topical route by the animal 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

49.895

kg

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Paralysis

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 02-Jun-2018, the dog developed acute hind limb paralysis. The dog was examined by the veterinarian, unspecified bloodwork was performed with the results unknown. The dog was adminsitered an unknown sedative and uspecified radiographs were performed with the results unknown. The dog was administered unknwon doses of methocarbamol and tramadol, both by mouth every 8 hours. The clinical sign continued. Update June 7 - product purchased at a different vet clinic. Advantage II XL. Dog has not improved as of June 7. Neither owner nor vet feels is product related


To be determined by Registrant

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

Major

19. Provide supplemental information here

N - Unlikely Serious nervous system disorders such as hind limb paralysis is not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to cause such signs in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But paralysis is not expected. Time to onset not consistent. Overall product involvement unlikely.