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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4447

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0037775 (Report 580630)

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.

09-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

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. 11556-142

Product Name: K9 Advantix II Medium Dog

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

7. b) Type of formulation.

Other (specify)

spot on

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).

In approximately 2016, an 8 year old, 18 pound, neutered, male, Shih Tzu 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

8.165

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavioural disorder NOS
  • Renal System
    • Symptom - Other
    • Specify - Renal disorder NOS
    • Symptom - Other
    • Specify - Urolithiasis
  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

Immediately post application, the dog exhibited an unspecified behavior change. The owner bathed the dog in an unspecified shampoo and the sign resolved approximately 4 hours post onset. On an unspecified date in 2016, the dog was examined by a veterinarian and diagnosed with kidney disease and bladder stones. On an approximately Mar 2019, the dog died at home. No known necropsy was performed. No more 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

O - Unclassifiable/unassessable Reported behavior change is unspecific and may have numerous other causes. Later diagnosed kidney disease and bladder stones are not expected in dog after product application. Other causes should be considered. Later reported death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Other causes should be considered in tis now 11 years old dog. Death in this case may be associated with underlying poor condition due unspecified kidney disease. No necropsy was performed. Though time to onset is very short for initial sign, considering very long (3 years) time to onset for later reported sign and overall aspects, a product relation is considered unassessable.