Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4461

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0042720 (Report 585283)

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.

25-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

10-FEB-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)

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

Product Name: K9advantixII pipette size unknown

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

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7. b) Type of formulation.

Other (specify)

Spot-on

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 approximately 01-Feb-2017, a 9 year old, male, Sheepdog - Shetland dog, of unknown weight, reproductive status and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner.

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

Shetland Sheepdog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 yr / > 1 an

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Neoplasia
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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

On approximately 10-Feb-2017, the dog developed lethargy. The dog was evaluated by a veterinarian and an ultrasound was performed. The dog was diagnosed with a kidney tumor (neoplasia NOS) with metastasis to the aorta (metastatic neoplasia). The dog continued to have the product applied monthly with the last dose being applied on approximately 01-Feb-2019. On 24-Feb-2019, the dog died. No necropsy was performed. No further information is expected. This case is closed. Note: Previous application was well tolerated.

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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

N - Unlikely Reported lethargy is an unspecific sign and may have numerous causes. In this case, it may rather be associated with diagnosed cancer. Kidney tumor with metastasis to aorta is not expected after product application. The active ingredients are not listed as mutagenic or carcinogenic. Time to onset is inconsistent, as a kidney tumor needs time to develop before it can be seen on ultra-sound. Other causes are more probable in this geriatric dog. Later reported death is not expected after product application as inconsistent with pharmaco-toxicological product profile. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Death in this case, likely associated with concomitant condition of kidney tumor. No necropsy was performed. Time to onset is long. Overall, a product relation is considered unlikely.