Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7490

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0068539 (Report 454028)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

19-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

17-OCT-17

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 Small 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).

On 19-Sep-2017, a 14 year old, approximately 12 pound, female, Pekingese dog, of unknown reproductive status and condition, with a concomitant medical condition of fleas and an unspecified kidney disease, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal 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

Pekingese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

5.443

kg

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

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 10-Oct-2017, the dog was examined by the veterinarian who performed unspecified blood work with unknown results, fleas continued to be seen and the collar was removed. On approximately 17-Oct-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 product efficacy and not to report the death in this event.

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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: Death is not expected following appropriate topical product application as inconsistent with products 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 dogs for an 8 months period without causing serious signs. Dog involved in this case was geriatric with unspecific kidney disease, and thus numerous underlying health conditions may be the cause for the death of this animal. Dog died one week after collar removal. Moreover, the reason for the initial phone call was to discuss product efficacy and not to report the death in this event. Presence of fleas is not a sign of inefficacy. The collar was worn less than 6 weeks and thus pupae may still emerge from the environment to re-infest the pet. Though product is effective, efficacy against fleas becomes apparent after this period. Finally, considering known product profile a product relation is unlikely.