Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7958

2. Registrant Information.

Registrant Reference Number: 2016KP239

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

20-APR-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

• 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).

On approximately 22-Mar-2016, a 1 year old, 74.7 pound, female, Labrador Retriever (Chocolate) canine, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

74.7

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Loss of appetite

• General
  • Symptom - Polydipsia

• Cardiovascular System
  • Symptom - Other
  • Specify - Circulatory Disorder
  • Symptom - Bradycardia

• Gastrointestinal System
  • Symptom - Weight loss

• Nervous and Muscular Systems
  • Symptom - Muscle weakness

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 20-Apr-2016, the dog developed lethargy, a decreased appetite, polydypsia and syncope. On 25-Apr-2016, the dog was examined by a veterinarian. On exam, the dog was found to have bradycardia, weight loss and unspecified muscle weakness. Blood work was performed, with the results unknown. No treatments were performed. On approximately 01-May-2016, the collar was removed. On 08-Jun-2016 the dog died. 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

Reported lethargy, decreased appetite and polydipsia are unspecific and may have numerous other causes. Signs are not expected to appear long time after collar application. Further reported syncope, bradycardia and muscle weakness are not expected after topical product application as signs inconsistent with pharmacotoxicological product profile. Weight loss is not expected either and may be related to the decreased appetite. Further reported death is unexpected and inconsistent with products pharmacotoxicological 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. Moreover, death is reported weeks post collar removal thus not related to product. Time to onset is exceptionally long. Although no necropsy performed, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.