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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0552

2. Registrant Information.

Registrant Reference Number: 2017KP060

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-JUL-14

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. 11556-142

Product Name: k9 advantix II medium dog

  • 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.

1

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).

On unknown dates in 2014, a 3.5 year old, 23 pound,neutered, female, Cavalier King Charles canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium Dog(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

Cavalier King Charles Spaniel

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 )

23

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Renal System
    • Symptom - Renal failure
    • Specify - kidney failure

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

On 01-July-2014, the dog was diagnosed with kidney failure and died. It is unknown if the dog had been examined by a veterinarian. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the expiration of the product and not to report the death in this event No further information is expected. This 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

Reported death is not expected in dog after product application, as it is inconsistent with pharmacotoxicological product profile. Moreover, dog was of advanced age. Other etiologies are more probable. Death is likely a consequence of diagnosed kidney failure. Moreover, the intent of the phone call to Bayer was to inquire the expiration of the product and not to report the death in this event. Finally, even though necropsy details and time to onset are unknown, overall, considering the products known profile and the fact that an alternative cause for death was identified, a product connection is deemed to be unlikely.