Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4152

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0033468

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.

11-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

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 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: 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).

A 45 pound, neutered, female, Beagle canine, in unknown condition, with a concomitant medical condition of pruritus, 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Beagle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15.5

7. Weight (provide a range if necessary )

20.412

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Neoplasia

• Gastrointestinal System
  • Symptom - Anorexia

12. How long did the symptoms last?

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

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 01-Mar-2016, a 15.5 year old, 45 pound, neutered, female, Beagle canine, in unknown condition, with a concomitant medical condition of pruritus, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unspecified date in Oct 2016, the dog had anorexia. The dog was examined by a veterinarian and was diagnosed with an unspecified neoplasm. No treatments or diagnostics were performed. On 01 Nov 2016, the collar was removed due to 8 months of use. On 22 Feb 2017, the dog died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No more 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 Anorexia is unspecific and may have numerous other causes. Other causes are more probable. Further serious sign of the diagnosed neoplasm and death is not expected as per the pharmaco-toxicological product 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, animal in this case was geriatric so might be predisposed to many other medical problems as well. Neoplasm could have also resulted in death. Moreover the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Considering all aspects, although no necropsy was performed, product involvement is deemed to be unlikely.