Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6647

2. Registrant Information.

Registrant Reference Number: 2016KP193

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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)

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

Product Name: K9 advantix II unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

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 an unknown date in approximately 2012, a 8 year old, 6 pound, neutered, female, Chihuahua canine, in unknown condition, with no known concomitant medical conditions, was administered an unknown amount of K9 Advantix II(unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was an extra label use of the product as only a partial pipette was administered.

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

Other

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 )

8

7. Weight (provide a range if necessary )

6

lbs

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Salivating excessively

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

Died

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

An unspecified time post administration, in 2012, the dog exhibited hypersalivation, vomited once and was lethargic. It is unknown if she was examined or treated by a veterinarian. On an unknown date post onset, in approximately 2012, the hypersalivation and lethargy resolved. On an unknown date in approximately 2016, the dog passed away. A necropsy was not performed. The reporting party was not calling to report the death of the dog but mentioned during the initial reaction report. No further information expected. Case closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported hypersalivation and vomiting are rather unspecific signs and may have multiple potential other causes. No oral uptake reported. Lethargy might be a consequence of reported vomiting. No time to onset reported. Death is not expected in a dog after product application, as it is inconsistent with pharmacotoxicological product profile. Other causes should be considered, however no necropsy was performed. Actually, the reporting party was not calling to report the death of the dog but mentioned regarding the same during the initial reaction report. Finally, even though time to onset is exceptionally long (4 years) for reported death, considering lack of information as no necropsy was performed, a product connection is unassessable.