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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3476

2. Registrant Information.

Registrant Reference Number: 2016CK081

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.

24-MAY-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-DEC-15

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

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

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).

A 43.6lb fs border collie was treated with 1 tube of k9 advantix II large dog on may 19th. the product was applied in multiple spots down the back. The dog has been treated with the product on previous occasions with no issues.

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

border collie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

19.8

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

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Gagging
  • Nervous and Muscular Systems
    • Symptom - Shaking
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Hyperthermia
    • Symptom - Lethargy
    • Symptom - Dehydration
  • Respiratory System
    • Symptom - Other
    • Specify - dry nose

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Euthanised / Euthanasie

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

4hrs after product application, the dog was vomiting (and vomited a sack like structure - possible balloon or plastic), the dog was also shaking, trembling and had a cold dry nose. The dog was eating less on may 20th and was lethargic. The dog had episodes of vomiting, coughing and gagging. On May 21st, the dog was drooling and was taken to an emergency veterinary clinic. Bloodwork was within normal limits. The dog was treated with sucralfate, cerenia and a low fat diet. Differential diagnoses at that time included gastroenteritis, pancreatitis, GI foreign body. On May 23rd, the dog was bathed. The dog was improved but continued to drool. The dog declined again. The pet owner declined diagnostics and surgery for a suspected GI foreign body. The dog had a temperature of 39.9 and was 5-7% dehydrated. The pet owner elected for euthanasia due to financial concerns on an unknown date in May 2016.


To be determined by Registrant

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

Major

19. Provide supplemental information here

please note the attending veterinarian did not think there was a relationship between the clinical signs and the product