Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5083

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0050744 (Report 593555)

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.

26-AUG-19

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

25-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. 11556-155

Product Name: Seresto Large Dog collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • 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 24-Aug-2019, an 8 week old, approximately 4 pound, intact, male, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was secondarily exposed to a Seresto Large Dog (Flumethrin-Imidacloprid) collar that was worn by a dog in the home. It was unknown if direct contact with the collar occurred.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.15

7. Weight (provide a range if necessary )

1.814

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Lethargy

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?

Other / Autre

specify secondarily exposed to collar that was worn by a dog, unknown if direct contact occurred

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On approximately 25-Aug-2019, the cat exhibited lethargy and seizures. On 26-Aug-2019, the cat died. The cat was not evaluated by a veterinarian and 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

O - Unclassifiable/unassessable No real off-label use not used on cat. No product exposure described. Even with accidental exposure, the reported signs are not expected. It is more likely that lethargy, seizures and death were due to other unrelated causes in this very young cat. The product is not anticipated to cause serious neurological disorders such as seizures or death after exposure of the product as the controlled release mechanism assures release of only low doses of active ingredient at a time. Even with oral product exposure, seizures are not seen. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset short. A product relation is deemed unlikely, however due to no information about the root cause, a product relation for the case was considered unassessable.