Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5918

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0052828 (Report 595713)

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-SEP-19

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

14-AUG-19

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. Unknown

Product Name: Seresto Collar - Confirmed Counterfeit

• Active Ingredient(s)
  • FLUMETHRIN
  • IMIDACLOPRID
    • Unknown

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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 an unspecified date in May-2019, an approximately 23 year old, approximately 14 pound, neutered, male, Maine Coon cat, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) Collar placed around the neck by the animal owner. The collar did not have a lot number printed. The reflectors came in a zip-lock style bag. The bag for the collar did not have a lot number printed and had unexpected EPA numbers. This collar is confirmed counterfeit.

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

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

23

7. Weight (provide a range if necessary )

6.35

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Parasitism

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Lethargy
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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 approximately 14-Aug-2019, multiple live fleas were visualized on the cat and the cat developed pruritus. On approximately 30-Aug-2019, an increased number of fleas were visualized on the cat. On 03-Sep-2019, the cat developed lethargy. On 04-Sep-2019, the cat 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

MAH: No assessment performed - This is a confirmed counterfeit case, this is not a BAH product. Hence, no assessment was performed.