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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0744

2. Registrant Information.

Registrant Reference Number: 2015KP372

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-NOV-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).

On 15-Oct-2015, a 10 year old, 40 pound, neutered, male,Crossbred canine, in good condition, with fleas and pruritus,had one Seresto Large Dog (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

Crossbreed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

40

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
  • Blood
    • Symptom - Other
    • Specify - Haemorrhage NOS

12. How long did the symptoms last?

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

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 16Oct2015, the pruritus resolved. On approximately 15Nov2015, the dog became pruritic. On 09Dec2015, the dog was found outside the yard deceased with blood coming from its mouth. The dog was not examined by a veterinarian and no necropsy was performed. No more information is expected and the 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

Location of pruritus unknown, but generalized pruritus not typically seen with product use. If any, skin reactions would be localized at the application site. Moreover pruritus was pre-existing which resolved initially and later reoccurred after exceptional long time to onset. Other causes (e.g. allergies) are more likely. Blood coming from mouth and death is not expected after topical product application as not in line with pharmaco-toxicological product profile. Oral exposure to the collar is not expected to cause death 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out. Hence even though no necropsy was performed, considering all aspects product involvement is unlikely.