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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2428

2. Registrant Information.

Registrant Reference Number: 2018RB014

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.

19-MAR-18

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

18-MAR-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 March 18, 2018 the pet owner applied Advantage II extra large to their 38.6 kg, female, 10 year old crossbred dog with a history of fear and abnormal neurological behavior as described 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

Crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

38.6

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 / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Aggressive behaviour
  • Eye
    • Symptom - Pupil dilation
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Symptom - Other
    • Specify - abnormal neurological behavior

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

Fully Recovered / Complètement rétabli

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

Within 15 minutes of application the dog had one of these episodes and became aggressive, with dilated pupils, and was shaking. All of these symptoms have been observed at various times in the dogs history prior to Advantage II exposure. Bathing was recommended by the health care provided and therefore the case is classigied as moderate. The dog recovered the following day.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

O-Unassessable: Reported aggression is a behavioural response to the product sensation. Shaking is not expected with appropriate topical product application. Sign may rather reflect a behavioural response to the product than true systemic sign. Further reported dilated pupils and other neurological signs are not expected with appropriate topical product use. No oral product exposure witnessed. However, considering consistent time to onset, a connection with accidentally ingested product cannot be ruled out entirely. Moreover, most of the signs were preexisting in this case. Considering all aspects, a product involvement is unassessable.