Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-4659

2. Registrant Information.

Registrant Reference Number: 36837

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.

30-AUG-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-JUN-21

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. 27581      PMRA Submission No.       EPA Registration No.

Product Name: advantage II small dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

---

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

Product Name: K9 ADVANTIX II PIPETTE SIZE UNKNOWN

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

---

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 14-Jun-2021, a 1 year old, 4 kg, male neutered Coton de Tulear in fair condition with a recent history of dental extractions was administered one ADVANTAGE II 6 X 0.4 ML SM DOG, (-), by Animal owner. The product was used according to label (Yes).

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

Coton de Tulear

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

4

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin

• General
  • Symptom - Discomfort

12. How long did the symptoms last?

Unknown / Inconnu

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

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

Within 3-4 hours of application the dog experienced itchiness and was uncomfortable. The pet owner bathed the dog with dog shampoo. The dog received an unknown dose of K9 Advantix II on an unknown date. On 14 Jul 2021 the dog received another dose of advantage II small dog. Within 3-4 hours of application the dog experienced itchiness and was uncomfortable. The symptoms were worse than the first application. The pet owner bathed the dog with dog shampoo. On 14 Aug 2021 the dog had another dose of advantage II small dog applied. 3-4 hours after application the dog experienced itchiness and was uncomfortable. The symptoms were worse than the previous two applications. The pet owner bathed the dog with dog shampoo. The veterinary clinic recommended applying vitamin E oil and administering Benadryl (diphenhydramine). The outcome is unknown.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here