Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6432

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0064062 (Report 530534)

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.

23-OCT-18

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

17-OCT-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.       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 %

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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 14-Oct-2018, a 10 year old, 60 pound, neutered, male, Retriever - Labrador crossbred dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar 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 (Retriever - Labrador x)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

27.216

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• General
  • Symptom - Lethargy
  • Symptom - Death
  • Symptom - Weakness

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 17-Oct-2018, the dog exhibited diarrhea and intermittent vomiting. On approximately 19-Oct-2018, the owner removed the Seresto collar and bathed the dog in dish liquid. On approximately 20-Oct-2018, the dog recovered without medical intervention. No further information is expected. This case is closed. Follow up received on 23rd Oct 2018: 20-Oct-2018, the dog recovered without medical intervention. On 25 Oct 2018, the dog died. A necropsy is pending. Follow up received on 26th Oct 2018: On approximately 20-Oct-2018, the vomiting and diarrhea resolved, but the dog was weak. On 24 Oct 2018, the dog developed diarrhea. On 25 Oct 2018, 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 diarrhoea and vomiting are unspecific signs and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility) however mild gastrointestinal signs may occur shortly after product application. Time to onset is rather long. Weakness is unspecific as well. In this case it may be consequence of gastrointestinal signs. 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. However no oral product exposure reported in this case. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Other unrelated causes must be considered in this geriatric animal. Time to onset is long. Considering low level of information (animal health status, medical history and necropsy report are unknown), a product relation is unassessable