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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0140

2. Registrant Information.

Registrant Reference Number: 2017BS063

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.

24-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

11-OCT-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. 27582      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

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).

Buda a 9 year old, M/N, 24.25 kg Corgi x cocker had Advantage II large dog applied to the dorsal midline on October 10th.

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

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

24.25

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

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

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Skin
    • Symptom - Irritated skin
    • Symptom - Pruritus
    • Symptom - Other
    • Specify - Skin sore

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

Buda a 9 year old, M/N, 24.25 kg Corgi x cocker had Advantage II large dog applied to the dorsal midline on October 10th. Within 24 hours owner noticed Buda was vocalizing, started chewing on hind quarters. Owner used mild soap and water to clean the area and applied Polysporin. On October 12th, dog was seen by vet. Buda self-traumatized the area which became irritated and produced open sores. Buda's treatment protocol involved sedation, Vanectyl P for itching, Baytril 250mg and Viaderm for wound. Reaction was moderate.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible A behavioural response to the product sensation or to the product smell may occur in a particularly sensitive animal. Generalized skin reactions or skin reactions on other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Time to onset is short. Considering all aspects, product relation is possible.