Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4228

2. Registrant Information.

Registrant Reference Number: 2016KP132

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.

26-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar - Dog

• Active Ingredient(s)
  • Flumethrin
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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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 23-Mar-2016, an 8 year old, approximately31 pound, neutered, male, Shih Tzu/Maltese crossbred canine, in unknown condition, with no known concomitant medical conditions, had 1 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

shih tzu/Maltese crossbreed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

31

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 - Rash
  • Symptom - Lesion

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Tachypnea

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Other
  • Specify - Abnormal Test Result
  • Symptom - Abnormal behaviour
  • Specify - Behavioural Disorder

12. How long did the symptoms last?

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

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 26-Mar-2016, the canine had signs of application site rash and an application site lesion. The collar was removed and the affected area was administered a topical neomycin/polymyxin/bacitracin ointment. On 27-Mar-2016, the ointment was discontinued. On 28-Mar-2016, the canine presented to the veterinarian with signs of abnormal behavior, lethargy, tachypnea, and anorexia. The signs at the application site were resolved. Blood work including a complete blood count revealed abnormal results; the specific blood work beyond the blood count and which values were abnormal were unspecified. Radiographs revealed no abnormalities. Treatments were recommended but the owner took the canine home. On 29-Mar-2016, the canine died at home. No known necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Transient mild application site disorders may occur in sensitive individuals shortly after product application. Other reported behavioural signs, non serious systemic signs and respiratory sign were reported after the removal of the collar are unspecific and may have other causes as well. Reported abnormal test result is not specified however any abnormality in blood work would not be expected after product administration. 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 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. Though time to onset for initially reported application site disorders is consistent, it is long for all other signs, particularly death. In conclusion, considering death as most prominent and severe sign, a product relation is deemed to be unlikely