Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2192

2. Registrant Information.

Registrant Reference Number: 2017KP136

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.

19-APR-17

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. 11556-143

Product Name: k9 advantix II large dog

• 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.

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).

On an unspecified date in 2015, a 15 year old, 21 pound,neutered, male, Schnauzer (Miniature) canine, in unknown condition, with no known concomitant medical conditions, was administered a partial tube of K9 Advantix II Large Dog(Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner who split the tube between applications. This was off label use as the dose amount was unknown.

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

Miniature Schauzer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

21

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

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Death
  • Symptom - Abnormal behaviour

12. How long did the symptoms last?

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

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

Immediately post application the dog exhibited lethargy and the behavior of not wanting to get up. Two days post application, on an unknown date in 2015, the lethargy and behavioral change resolved. On an unspecified date post application in 2015, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected. Case is 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 lethargy and the behavioural disorder are very unspecific signs and may have multiple causes. Later reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction reported. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Other etiologies more probable. Moreover dog was of advanced age. Though time to onset for initial signs is short, considering unknown but apparently rather long time to onset for fatal outcome, a product connection is deemed unlikely.