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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1054

2. Registrant Information.

Registrant Reference Number: 2018CP008

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.

23-JAN-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

08-DEC-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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II large cat

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 December 01 2017 , an 2. kg, 8 months old female canine chihuahua with no concomitant medical condition ; was applied one tube advantageII large cat once topically by the owner.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.666

7. Weight (provide a range if necessary )

2

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

  • Gastrointestinal System
    • Symptom - Diarrhea
  • Renal System
    • Symptom - Other
    • Specify - dilute urine
  • General
    • Symptom - Polydipsia
  • Renal System
    • Symptom - Frequent urination

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

One week after application, the dog had loose stool , had increased urination and increased thirst. Dog was examined by a veterinarian on January 22 and had dilute urine. Unknown outcome.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

N-Unlikely: This is an off-label use as cat product applied on dog. Reported loose stools is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. Reported renal disorders and increased thirst are not expected after topical product application as inconsistent with the pharmaco-toxicological product profile. Time to onset is long. Overall, a product relation is considered unlikely.