Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1624

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0009617 (Report 475419)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississauga

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.

21-MAR-18

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 (unspecified)

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • 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 an unknown date in 2010, an 8 year old, neutered, female, Crossbred canine, of unknown weight and condition, with fleas and ticks, was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) topically by the 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

Crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Seizure
  • Symptom - Rigidity
  • Symptom - Unresponsive

12. How long did the symptoms last?

Persisted until death

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

Starting approximately 1 week post administration in 2010, the canine exhibited a seizure, which consisted of the canine sitting down, splaying out her legs, swaying her body (ataxia), and being unresponsive for approximately 5 minutes. The canine continued to be administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) topically by the owner monthly for 6 months. During that timeframe, the seizure episodes were of short duration and continued intermittently; the canine was also examined by a veterinarian an unspecified number of times. It is unknown what, if any, diagnostics or treatments were provided. After the 6 monthly applications in approximately 2010, the product was discontinued and the signs resolved. On unknown date in 2017, the canine died at 15 years of age. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This 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

N - Unlikely It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. ataxia, may occur even after oral uptake. Sitting down, splaying of legs and being unresponsive are not expected after product application and are likely a consequence of reported seizure. Positive re-challange and de-challenge, however events only reported after 7 years likely affecting the quality of information. Later reported death is not anticipated after product application as it is inconsistent with the pharmaco-toxicological product profile. Moreover, the product use was discontinued for a very long duration (approximately 7 years). Other causes are more probable in this geriatric dog. In the end, a product connection is deemed to be unlikely.