Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4016

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0020558

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

28-FEB-16

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 Small

• 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.

38

Other Units: cm

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).

1 Seresto Small Dog (Flumethrin-Imidacloprid) collar 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

2.722

kg

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

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

• Renal System
  • Symptom - Other
  • Specify - Renal disorder NOS

• Gastrointestinal System
  • Symptom - Anorexia

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 2016, a 4 year old, 6 pound, male, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, who was bathed once a week in an unknown shampoo since an unknown date in 2016, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 28-Feb-2016, the dog was anorexic. On approximately 29-Feb-2016, the dog was examined by the veterinarian. The dog had an unspecified type of laboratory blood profile performed, had a positive test result for Lyme disease and was diagnosed with kidney disease. On approximately 6-Mar-2016, the dog died at home. It is unknown if a 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 Reported anorexia is unspecific and it is likely associated with the later diagnosed lyme disease. 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. Thus, infection with tick borne diseases (lyme disease) despite wearing a collar can occur exceptionally and is consistent with the products claimed efficacy as addressed in the product information. Diagnosed kidney disease and further reported death are not expected after topical product application as inconsistent with pharmaco-toxicological product profile. Diagnosed kidney disease may be associated with diagnosed lyme disease. Oral exposure to the collar is not expected to cause serious signs either. Product has wide margin of safety. In this case, cause of death may probably be diagnosed lyme disease and kidney disease thus, sufficient information exists to rule out product involvement. Time to onset is unknown for initial reported signs but seems longer for death. Even though some information (e.g. health status and necropsy results) is not available, considering the known safety product profile and alternative causes identified, a product involvement is deemed to be unlikely.