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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4284

2. Registrant Information.

Registrant Reference Number: 2016KP163

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-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

18-JUN-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. 11556-155

Product Name: Seresto Collar - 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 18-Jun-2016, a 3.5 year old, 140 pound, neutered,female, Newfoundland canine, in good condition, with no known concomitant medical conditions, had 1 Seresto LargeDog (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

Newfoundland

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

140

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 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Dyspnea

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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

Approximately 4 hours post administration, the canine exhibited lethargy, vomiting, and anorexia. On 19-Jun-2016, the canine was examined by the veterinarian. Unspecified blood work was performed and revealed no abnormalities. On 20-Jun-2016, the canine examined by the veterinarian. Unspecified radiographs were performed and revealed no abnormalities. The canine was administered an intravenous catheter, started on an unknown fluid solution by intravenous route, administered injections of maropitant citrate and famotidine by unknown route, and hospitalized. On 21-Jun-2016, the canine exhibited agonal breathing and died. On 22 Jun 2016, the attending veterinarian performed a necropsy on the canine and found no gross abnormalities. The heart, liver and kidney were submitted for histopathology. Results are unknown.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Reported systemic signs are likely associated with vomiting than the product. Dyspnoea 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 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset long for the serious sign where as it is short for others. Histopathology results unknown. Considering the product profile, product involvement is deemed unlikely, however due to short time to onset and at present missing alternative cause, a product relation is unassessable.