Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2421

2. Registrant Information.

Registrant Reference Number: 2018EB038

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.

03-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-MAY-18

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII medium dog

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

The patient is a 5.6kg MN 9 year old toy poodle. On May 2nd the pet owner applied 1 dose of K9 Advnatix II medium dog topically.

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

Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

5.6

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Skin
  • Symptom - Erythema
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting
  • Symptom - Other
  • Specify - tenesmus

• Renal System
  • Symptom - Other
  • Specify - stranguria
  • Symptom - Other
  • Specify - bladder obstruction

• General
  • Symptom - Neoplasia
  • Specify - prostatic

• Renal System
  • Symptom - Painful urination

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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

Less than 12 hours later, the patient had some redness at the site of application and application site pruritus. The patient also developed diarrhea. The patient was seen at the clinic on May 3rd and was treated with an anti-inflammatory and an anti-histamine injection. on May 7 the dog was vomiting and was treated with injectable cerenia, oral metronidazole and fortiflora. the vomiting and diarrhea ended on May 10. On May 17 the dog was examined as he had been vomiting occasionally since May 14; Biochemistry and CBC blood work was normal. Dog was given a cerenia injection. on June 07 dog started to have stranguria and tenesmus. Abdominal Xrays and blood work were normal on June 7. dog was treated with Metacam,metronidazole and cerenia. on June 8, dog was seen at an emergency clinic for dysuria: physical exam was normal and dog was sent home; dog had more stranguria and bladder obstruction on June 14 and was admitted to a referral hospital and a urinary catheter was inserted to relieve the obstruction . On June 15 ,an ultra sound revealed possible prostatic neoplasia; dog was euthanized at the owner's request

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To be determined by Registrant

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

Major

19. Provide supplemental information here

unlikely Redness and pruritus at the site of application site most likely reflect local dermal sensitivity to the product. Diarrhea is rather unspecific sign in dogs and may have multiple potential causes. Potential oral uptake was not reported. Later reported stranguria is not expected, however in this case it is likely a consequence of further diagnosed prostatic neoplasia. Further diagnosed enlarged and heterogeneous prostate with central mass of mineralization, diagnosed prostate neoplasia, chronic changes in the left kidney and need for euthanasia are not expected in dogs after product application, as inconsistent with pharmaco-toxicological product profile. However owner may have decided to euthanize the dog due to diagnosed prostate neoplasia. Other causes are more likely. Though time to onset is consistent for initial signs, prostate enlargement with subsequent stranguria 35 days after product application was likely pre-existing. In the end, a product connection is considered unlikely.