Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3144

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0021207 (Report 702242)

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.

21-MAY-21

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

01-JUL-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 approximately 15-May-2018, an 11 year old, male, Domestic Shorthair cat, of unknown weight and reproductive status, in unknown condition, with the concomitant medical condition of Feline Immunodeficiency Virus, had 1 Seresto Cat (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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

Unknown

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Other
  • Specify - Increased Appetite

• General
  • Symptom - Lethargy
  • Symptom - Abnormal behaviour

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Impaired consciousness

• General
  • Symptom - Death
  • Symptom - Parasitism

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 approximately 01-Jul-2018, the cat developed increased hunger and unspecified weight loss. On approximately 15-Jul-2018, the cat developed lethargy. On approximately 01-Aug-2018, the cat was laying in the sink (behavioral changes NOS). The cat was bathed with an unspecified flea shampoo and live fleas were visualized on the cat. On approximately 15-Aug-2018, the cat was laying in the litter box (behavioral changes NOS) and exhibited impaired consciousness. The cat was evaluated by the veterinarian but died before any treatments could be performed. The intent of the call was not to report the death of the animal but rather to inquire about product use in general. No further information is expected. This case is closed

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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 SLEE/fleas. Reported increased hunger, unspecified weight loss, lethargy, behavioural signs are very unspecific and may have numerous other causes. Presence of fleas is not necessarily a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Fleas were reported after a flea-free time. Sudden appearance of fleas after flea-free time suggests re-infestation with fleas from environment (e.g. other untreated pets, wildlife). This may lead to new establishment of a flea population in pets environment requiring several weeks of treatment to disappear. Further, potential contributing factors e.g. high risk area or high infestation pressure were not clarified. Reported impaired consciousness and death are 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 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. The geriatric cat had a concomitant condition of feline Immunodeficiency virus which may have contributed to the signs. Moreover, the intent of the call was not to report the death of the animal but rather to inquire about product use in general. Time to onset is long. Overall due to limited information regarding Veterinary diagnosis and necropsy, case is considered unassessable.