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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6656

2. Registrant Information.

Registrant Reference Number: 2016KP202

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-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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: K9 advantix II unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: mL

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).

Limited information was obtained at the time of the communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about about product use on another pet within the household and not to report the death of this animal. On an unspecified date in approximately 2015, an 8 year old,male, Retriever (Golden) canine, of unknown weight,reproductive status and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II(unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically 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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Behavioural disorder

12. How long did the symptoms last?

Unknown / Inconnu

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

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

At an unspecified time post application in 2015, the dog exhibited rolling on his back (behavioral) and pruritus. On an unspecified date in Jan-2016, the dog died. No known necropsy was performed. No further information is expected; case closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Pruritus is not expected to be generalised but rather be linked to the application site. Reported rolling on back is a very unspecific sign and may have numerous other causes. Later reported death is not expected in dog after product application, as inconsistent with pharmacotoxicological product profile. Though time to onset unknown for death either, likely much more over 1 day, therefore anaphylactic shock can be ruled out. Other causes are more likely. Intent of the phone call to Bayer was to inquire about product use on another pet within the household and not to report the death of this animal. Considering all aspects, product connection deemed to be unlikely.