Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6455

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0060420 (Report 603460)

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.

07-OCT-19

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

01-OCT-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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Small Dog Collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

---

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 2018, a 9 year old, 20 pound, neutered, male, Chihuahua canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. This was extra label use as a low dose.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

9.072

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Abnormal behaviour
  • Specify - Behavioural disorder NOS

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Weakness

• Nervous and Muscular Systems
  • Symptom - Collapse

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 an unspecified date post application in 2018, the collar was removed. On approximately 09-Sep-2019, the dog had 1 Seresto Large Dog (Flumethrin-Imidacloprid) placed around the neck by the owner. On 01-Oct-2019, the dog exhibited the behavior of pulling the head through the collar and removed the collar from himself. Immediately post removal, the dog exhibited falling and weakness. Approximately 5 minutes post removal, the dog collapsed and died. No necropsy was performed. The dog was not examined by a veterinarian and no known treatments were performed.

---

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 Reported behavioural disorder and weakness are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Other causes are more probable. Falling is not typically seen with appropriate topical product administration. Further, reported collapse followed by death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause such 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Moreover, initial collar was well tolerated by the animal and this collar was tolerated without any Problems for several weeks. Time to onset is long. Overall, a product involvement is considered unlikely, however as no alternative case present case classified as unassessable.