Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6940

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0060705 (Report 447189)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

18-SEP-17

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSISSIPPI

6. Date incident was first observed.

03-JUN-17

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
  • 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: Forest - Woods / Forêt et boisés

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On 21-Nov-2016, a 6 year old, 27.6 kilogram, neutered, female, Retriever (Golden) canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around her 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

27.6

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Paralysis

• Respiratory System
  • Symptom - Dyspnea

• General
  • Symptom - Pale mucous membrane colour

• Blood
  • Symptom - Leukopenia

• General
  • Symptom - Other
  • Specify - Abnormal test result

12. How long did the symptoms last?

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

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 03-Jun-2017, the canine was examined by the attending veterinarian and an unknown number of ticks were found on the canine. The canine was diagnosed with tick paralysis, the collar was removed, and the canine was bathed. A new Seresto Large Dog collar (Flumethrin-Imidacloprid) was placed around its neck by the attending vet. The signs continued. On 21 Jun 2017, the signs worsened and the canine had trouble breathing. She was examined by the attending vet, had pale mucus membranes, a low white blood cell count, and was diagnosed with Ehrlichia Canis. The canine was hospitalized. Treatments were unknown. The canine died and no necropsy was performed.

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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: In case of attachment of ticks these will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the products claimed efficacy. This issue is addressed in the product information. Later reported signs, troubled breathing, pale mucous membrane and low white blood cell count are not expected with topical product application and may be associated with the diagnosed Ehrlichiosis. 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. Outcome is mostly associated with earlier reported signs caused due to tick paralysis and Ehrlichiosis . Though some information is not known (state of health, necropsy results) considering long time to onset and signs in chronology with diagnosed disease, a product relation is considered unlikely.