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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7413

2. Registrant Information.

Registrant Reference Number: 2017CK170

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.

16-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-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)

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).

3kg 16week male intact dmh treated with partial dose of advantage II XL on November 15th. started twitching 30 minutes later. (Unauthorised species- Dog product used on cat)

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Medium Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.30

7. Weight (provide a range if necessary )

3

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Recumbent
    • Symptom - Muscle twitching

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

3kg 16week male intact dmh treated with partial dose of advantage II XL on November 15th. started twitching 30 minutes later. taken to emergency clinic - recumbent, tremors and twitches. treated with methocarbamol. responded well. bloodwork normal. twitches recurred at home so returned to veterinary clinic. responded well to methocarbamol. will be discharged later today. Another kitten also treated with Advantage II XL remains asymptomatic.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Off label use as dog product used on cat. Neurological signs are not typically observed with appropriate topical product administration, however are possible with or administration of an overdose. Recumbency is not expected with appropriate product use however it may be associated with the reported neurological signs. Time to onset short. A product involvement is deemed to be possible.