Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5939

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0058477 (Report 601390)

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.

28-SEP-19

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

26-SEP-19

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. 11556-155

Product Name: Seresto Collar Large

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: COLLAR

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 approximately 2019, a 2 year old, 60 pound, neutered, male, Crossbred Canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

27.216

kg

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

• Skin
  • Symptom - Lesion
  • Specify - Wounds and lacerations

• Nervous and Muscular Systems
  • Symptom - Lameness

• General
  • Symptom - Polydipsia

• Nervous and Muscular Systems
  • Symptom - Recumbent
  • Symptom - Ataxia

12. How long did the symptoms last?

Unknown / Inconnu

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

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 26-Sep-2019, the dog was in a fight with another dog in the home and exhibited limping, multiple puncture wounds on the limbs, multiple lacerations on the limbs and excessive thirst. On 27-Sep-2019, the dog exhibited recumbency, was unable to stand or walk without assistance (walking difficulty). The dog was examined by a veterinarian, hospitalized and a complete blood count was performed. The dog was administered unspecified fluids intravenously and administered an unspecified anesthesia by the attending vet. The puncture wounds and lacerations were repaired and the dog was administered an unspecified antibiotic intravenously by the attending vet. On approximately 28-Sep-2019, the dog died.

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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

O - Unclassifiable/unassessable Reported limping, puncture wounds, laceration, excessive thirst and recumbency are not expected after topical product application. In this case, signs are likely consequence of fight with other dog. Further reported neurological disorders are not typically seen with appropriate topical product administration. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Considering the product profile, product involvement is deemed unlikely, however due to limited (animal health status, medical history, time to onset, necropsy report) information, product relation for the case is considered as unassessable.