Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2632

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0017239 (Report 697944)

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.

29-APR-21

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. 11556-155

Product Name: Seresto small dog

• 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 01-Apr-2021, a 10 year old, 12 pound, male, Pomeranian/Poodle (Miniature) canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small 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 ( Pomeranian x Poodle (Miniature))

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

5.443

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Shakiness
  • Symptom - Ataxia

• General
  • Symptom - Adipsia

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

Unknown

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 12Apr2021 the dog developed ataxia and shaking. On 20Apr2021 the dog had a seizure that lasted an unspecified length of time. On 22Apr2021 the dog was examined by a veterinarian and no treatment was completed. On 26Apr2021 the dog developed anorexia and adipsia. The owner removed the collar and the dog was bathed with an unspecified shampoo. On 28Apr2021 the dog died and no 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

O - Unclassifiable/unassessable Reported ataxia is 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. Shaking is not expected with product application but is likely associated with reported ataxia. Further, product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g., heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Seizures were not verified by veterinarian neither any treatments were performed. Reported anorexia and adipsia are unspecific and may have numerous other causes. Signs are not expected to occur long time after collar application. Further, death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. No serious signs reported in close proximity to death. Time to onset is long. Animal's health status and medical history if any is unknown. Also, no necropsy was performed. Other unrelated causes must be considered in this geriatric dog. Considering overall aspect, product relation to the case is unassessable.