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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2742

2. Registrant Information.

Registrant Reference Number: 2016KP060

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.

04-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

30-AUG-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 - Large Dog

  • 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 approximately 08-Aug-2015, a 10 year old, 32 pound,neutered, female, Spaniel (Cocker) canine, in good condition,with no known concomitant medical conditions, had 1 Seresto Large Dog 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Cocker Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

32

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Loss of appetite
  • General
    • Symptom - Polydipsia
  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

On approximately 30-Aug-2015, the collar was removed and the dog was bathed with an unspecified shampoo. Approximately 1 hour post collar removal, the dog began having diarrhea, a decreased appetite, polydpsia, alopecia, and was lethargic. On several unspecified dates in 2015, the dog presented to the veterinary clinic for evaluation. The veterinarian performed bloodwork and urinalyses that were normal. It is not known if any treatments were performed. On 30-Oct-2015, the dog died. No 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

Diarrhea is an unspecific sign and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Decreased appetite, polydipsia and lethargy may be associated with diarrhea indicating other unrelated causes. Location of alopecia is unknown, but generalized signs not expected with product use. If any, sign would be localized at the application site. All these sign were reported after collar removal and in close proximity of bathing with shampoo. Further, 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 or death either. An overdose of 5 collars around the neck was investigated in adult dogs for an 8 months period without causing serious signs. All the signs including fatal outcome was reported after collar was removed. Hence, other unrelated causes are more probable in this geriatric dog. Finally, even though no necropsy was performed, considering chronology and the known product profile, product relation can be ruled out.