Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3138

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0023032 (Report 564578)

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.

17-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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 Large Dog Collar (Flumethrin-Imidacloprid)

• 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 Oct 2018, a 4 year old, neutered, female, Bulldog/Beagle crossbred canine, of unknown weight and condition, with no known concomitant medical conditions, had 1 Seresto Large Dog Collar (Flumethrin-Imidacloprid) 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Bulldog X Beagle crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

Unknown

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

• Renal System
  • Symptom - Renal failure

• General
  • Symptom - Death
  • Symptom - Abnormal behaviour
  • Specify - Behavioural disorder NOS
  • Symptom - Parasitism
  • Specify - Other abnormal test result NOS

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 an unspecified date in Apr2019, the dog exhibited behavior change. On 01May2019, the dog was examined by a veterinarian, diagnosed with acute kidney failure and was positive for Lyme disease. On 06May2019 the dog died. It is unknown if a necropsy was preformed. 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

N - Unlikely Reported behavioural sign is unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. In this case, no ticks seen on dog. 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. The dog was diagnosed with Lyme disease. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the product's claimed efficacy. This issue is addressed in the product information. Further, reported acute renal failure and death are 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Serious outcome may be associated with diagnosed lyme disease. Time to onset is long. Overall, a product involvement is unlikely.