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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2823

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0026288

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.

05-JUN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

22-MAY-20

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Large Dog

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

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 approximately 30-Mar-2020, a 10 year old, approximately 140 pound, neutered, male, Boxer (German Boxer)/Great Dane crossbred dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal 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 (German Boxer x Great Dane)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

63.503

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Trembling
  • General
    • Symptom - Death

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?

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 22-May-2020, the dog exhibited ataxia and tremors. The owner removed the collar and bathed with liquid dish soap by recommendation of a veterinarian. On 03-Jun-2020, the dog died. No necropsy was performed. No further information is expected this case is closed. Note: No quality issues were noted upon product investigation.


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 neurological signs namely ataxia and tremors 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. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Time to onset is long. Other causes must be considered although not described. Further reported 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. Moreover, death is reported long time after collar removal. Other unrelated causes are more probable for the death of this geriatric dog. In the end, considering limited information (no necropsy details and unknown health status), a product relation to the case is unassessable.