Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4047

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0014832

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

Unknown

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 Collar Cats

  • Active Ingredient(s)
    • FLUMETHRIN
    • 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 2015, a 10 year old, approximately 6 pound, neutered, male, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) 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?

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 )

10

7. Weight (provide a range if necessary )

2.722

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Weight loss
  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Death
  • Liver
    • Symptom - Hepatic failure

12. How long did the symptoms last?

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

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 an unspecified date in 2015, a 10 year old, approximately 6 pound, neutered, male, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. Approximately 2 weeks post collar placement on an unspecified date in 2015, the cat developed weight loss and application site alopecia. Approximately 2 months post collar placement on an unspecified date in 2015, the cat was examined by a veterinarian; blood was collected for unspecified blood work that was performed and the cat was diagnosed with liver failure. The cat died and no necropsy was performed. The collar was removed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. This case is closed.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

N - Unlikely The reported application site alopecia may occur in sensitive animals after product application. It is usually mild and transient. Sign is consistent. Reported weight loss, subsequently diagnosed liver failure and death is 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. Product has wide margin of safety. Animal involved in this case was geriatric and likely died due to liver failure. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 years). Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset is short for initial signs, but it is long for this serious outcome. Even though some information is not available (health status, medical history and necropsy result), considering the known product profile and serious outcome of the case, a product involvement is deemed to be unlikely.