Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2761

2. Registrant Information.

Registrant Reference Number: 2016KP079

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.

04-MAY-16

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 Collar - unknown

• 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: 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).

Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such besought. The reason for the initial call was to discuss the efficacy of the product and not to report the death of the patient.On an unknown date in approximately Mar2015, a male,Retriever Labrador (No Description) canine, with an unknown age and weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog(unspecified) (Flumethrin-Imidacloprid) collar placed around his 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Abnormal Test Result
  • Symptom - Other
  • Specify - Systemic disorder

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 unknown date in approximately Apr2015, the dog developed unspecified systemic signs. He had unspecified blood work done and was diagnosed with Lyme Disease (abnormal test result). It is unknown what treatments, if any, where performed. On an unknown date in 2015, the dog passed away. It is unknown if a necropsy was performed. No further information expected. Case 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

The nature of systemic signs reported is unknown; however these signs could be related with later diagnosed Lyme disease. Lyme disease is a tick borne bacterial disease. In this case, no ticks seen on dog. As per the labelled claim of efficacy of the product, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn, 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 as addressed in the product information. Death is unexpected as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death either. The product has a high margin of safety. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Rather, death was likely an outcome of the Lyme disease. Moreover, the owner did not believe in product involvement either as reason for the initial call was to discuss the efficacy of the product and not to report the death of the patient. Overall, in spite of the limited information (animal and product details, unknown if necropsy was performed and unknown time to onset), sufficient information exists to rule out the product involvement. Thus, product relation is unlikely.