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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4684

2. Registrant Information.

Registrant Reference Number: 2018BS020

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-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-APR-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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II Extra Large Dog

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

1 tube of K9 advantix II XL dog was applied to (name) an 8 month old, 33.8 kg, Male, Golden Retriever along the dorsal midline on April 13, 2018.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.67

7. Weight (provide a range if necessary )

33.8

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Dermatitis
    • Symptom - Lesion
    • Specify - Application site scab
    • Symptom - Pruritus
    • Symptom - Inflammation of the skin

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

About 12 hours later, dog developed a quarter size area of moist dermatitis on the right mandible ~10cm x 3cm. Scabbing was present on dorsal neck area at application site, pruritis and inflammation at application site. Dog was examined by vet on May 2nd/2018. Owner reported the dog was bitten by another dog on May 1/18. Dog was prescribed Cefaseptin 750mg 1 tab BID for 10 days and Vanectyl P 2 tabs SID for 5 days.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Whereas skin reaction at application site, e.g. pruritus may occur in sensitive animals, would not expect scab and inflammation development directly related to product. However, likely linked to scratching at application site which caused skin lesions by self-trauma. Moist dermatitis on the mandible is not expected after product application. Considering consistent time to onset and application site involvement, a product connection is deemed to be possible.