Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6613

2. Registrant Information.

Registrant Reference Number: 2018EB210

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.

22-AUG-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-AUG-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)

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PMRA Registration No. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII large dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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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).

The patient is a 7 year old male neutered 22.8 kg poodle mix. The pet owner applied 1 vial of K9 Advantix II large dog on August 7th topically in multiple spots along the spine.

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

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

22.8

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• Skin
  • Symptom - Blister
  • Symptom - Erythema

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Erythema and blistering lesions were noted on the sites of application of the K9 Advantix II on August 12th. The patient was seen on August 17th, at the time of the exam, the lesions had mostly resolved. The patient was already on Atopica, Ketoconazole and oral immunotherapy to control atopy. The patient had been on these 3 treatments for years without issues and the atopy is well controlled. outcome is recovered

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

B - Possible - Whereas skin reaction at application site, e.g. erythema may occur in sensitive animal, would not expect application site blister development directly related to product. however, likely dog scratched at site and caused sign by self-trauma. Pruritus was not reported, however considering application site involvement and consistent time to onset, a product connection is deemed to be possible.