Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6756

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0070090 (Report 536894)

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.

27-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

23-NOV-18

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 Cat

• 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 21-Nov-2018, a 15 year old, neutered, male, Domestic Longhair feline, of unknown weight and condition, with concomitant medical conditions of hyperthyroidism and arthritis, being administered 2.5 mg methimazole every 12 hours since 2015, had 1 Seresto Cat (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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Vomiting
  • Symptom - Inappropriate defecation
  • Specify - Inappropriate defecation

• Nervous and Muscular Systems
  • Symptom - Convulsions

• Respiratory System
  • Symptom - Panting

• General
  • Symptom - Hyperactivity

• Skin
  • Symptom - Other
  • Specify - Piloerection

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Vocalizing
  • Symptom - Abnormal behaviour

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

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

Approximately 2 hours post administration the collar was removed. On 22-Nov-2018, the collar was reapplied around the neck of the feline by the owner. On 23-Nov-2018 approximately 11 hours post reapplication, the exhibited abnormal behavior and the collar was removed. On 26-Nov-2018, the sign was resolved and collar was again reapplied around the neck of the feline. Approximately 10 hours post administration, the feline exhibited seemed more loving (behavior change). On 27-Nov-2018 approximately 12 hours post collar reapplication, the feline exhibited drooling, vomited once, defecated on the floor and began having convulsions. The collar was removed. Approximately 30 minutes post removal, the neck of the feline was washed with dish soap on the recommendations of an unknown emergency veterinary clinic staff member. Approximately 1 hour post collar removal, the convulsions worsened and the feline also exhibited panting, agitation, vocalization, fur on tail puffed us and running in circles for approximately 2 hours. The convulsions continued to worsen and at 6 am approximately 4 hours post collar removal the feline 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

O - Unclassifiable/unassessable Reported behavioural disorders are unspecific and may have various other causes. The product is not anticipated to cause serious neurological disorders such as convulsion after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens for a 6 months period did not cause 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. Even with oral product exposure, convulsions are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Reported gastrointestinal signs, panting, agitation, vocalization, fur on tail puffed and running in circles are associated with convulsions. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. This is a geriatric animal having concomitant medical condition of hyperthyroidism and arthritis. Outcome was the consequence of reported convulsion. Collar was put on and off various times thus time to onset is difficult to define. Considering all aspects, product relation is unassessable.