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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3548

2. Registrant Information.

Registrant Reference Number: 2016TH012

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-MAR-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-MAR-16

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. Unknown

Product Name: Seresto Large Dog

  • Active Ingredient(s)
    • Flumethrin
    • IMIDACLOPRID

7. b) Type of formulation.

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).

Product is US product applied in Canada

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

Dog / Chien

3. Breed

Standard Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

27.4

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Diarrhea

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

Fully Recovered / Complètement rétabli

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 18Mar2016, a 7 year old, 60.4 pound, neutered, male, Poodle (Standard) canine, in fair condition, with a history of seizures, skin allergies, and anxiety, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around his neck by the owner. Approximately 2 hours post administration, the dog exhibited a change in behavior and was lethargic, so the collar was removed. On 19Mar2016, the dog recovered. On 20Mar2016, the Seresto collar was reapplied and approximately 2 hours post administration the dog developed diarrhea. The collar was removed. He was not examined or treated by the veterinarian and the diarrhea continued. The same product was used in 2015 with no concerns. This collar was reapplied March 27 as the dog had recovered by March 26 and the owner has not reported any adverse events since reapplication. The dog's owner is blind and the dog often eats inappropriate items.


To be determined by Registrant

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

Minor

19. Provide supplemental information here