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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6639

2. Registrant Information.

Registrant Reference Number: 2018RB141

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.

15-AUG-18

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

17-JUL-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage II pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 July 14, 2018 the pet owner applied Advantage II (unknown dose) to their 36.4 kg, male neutered, 12 year old crossbred dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

36.4

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Skin
    • Symptom - Rash
    • Symptom - Itchy skin
    • Symptom - Dermatitis
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Recumbent
    • Symptom - Muscle spasm
    • Symptom - Abnormal gait
    • Specify - Gait abnormality
    • Symptom - Other
    • Specify - knuckling
  • Skin
    • 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

On July 17, 2018 the dog developed localized itchiness on the ventral abdomen, and a localized rash on the ventral abdomen. The dog was seen by a veterinarian and was found to have a bacterial dermatitis and was placed on clavasceptin. The dog initially improved, then the symptoms returned. On August 13, 2018 the dog had a sudden onset of being unable to walk, was unable to rise, had muscle spasms, and an abnormal gait. The dog was also knuckling and was scratching at his abdomen while sleeping and still had inflamed skin. The dog was placed on an antibiotic, Benadryl, prednisone, and unspecified pain medication. Cytology revealed a yeast skin infection and the dog was started on a chlorhexadine bath. 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