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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4159

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0035035

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.

11-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

23-MAR-17

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 Small 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).

A 6 year old, male, Chihuahua dog, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Anorexia
  • General
    • Symptom - Death

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.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On approximately 01-Mar-2017, a 6 year old, male, Chihuahua dog, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On approximately 23-Mar-2017, the dog exhibited anorexia and diarrhea. On approximately 26-Mar-2017, the dog died. The dog was not evaluated by a veterinarian. No known necropsy was performed. Limited information was obtained at the time of communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about product use with another pet and not to report the death of this animal. No futher information isexpected. 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

N - Unlikely Initially reported diarrhoea and anorexia are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though these signs may occur initially after collar administration, they are not expected after several weeks of wearing the collar. Later reported death is not expected either as per the pharmaco-toxicological product profile. Oral exposure to the collar, which was anyway not reported in this case, 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. Time to onset too long. Other causes are more likely. Moreover the initial phone call was intended to discuss the use of the product and not to report the death of the patient. Finally, even though no necropsy was performed, considering all other aspects, product involvement is unlikely.