Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6718

2. Registrant Information.

Registrant Reference Number: 2016KP276

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-JUN-15

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

  • 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).

Limited information was obtained at the time of the communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about collar efficacy for the other dogs in the household and not to report the death of this animal.On approximately 01-Jun-2015, a 14 year old, 27 pound,neutered, female, crossbred canine, in unknown condition,with no known concomitant medical conditions, had 1 SerestoDog (unspecified) (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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

27

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Neoplasia

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-Nov-2015, the canine was examined by a veterinarian who diagnosed an unspecified cancer. On approximately 01-Feb-2016, the owner removed the collar as it had reached its duration and the canine had 1 new Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 01-Jun-2016, fleas were seen, so the owner removed the collar and placed 1 new Seresto Dog (unspecified) (Flumethrin-Imidacloprid) around the neck of the canine. On 15-Jul-2016, the canine died. No known necropsy was performed. 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

SLEE/fleas. Reported cancer 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 such 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. Animal was reported to be in advanced age. Death may be the likely consequence of earlier diagnosed cancer in an animal. Further the owner did not believe in product involvement either as the reason for initial call was to inquire about collar efficacy for the other dogs in the household and not to report the death of this animal. Presence of fleas is not 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. Time to onset is quite long for the reported serious events. Although no necropsy was performed sufficient information exist that the product involvement is unlikely.