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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4460

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0042692 (Report 585274)

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.

25-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

01-FEB-19

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. 11556-144

Product Name: K9advantixII extra large 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.

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).

On approximately 15-Jan-2019, a 9 year old, male, Shepherd Dog - German dog of unknown weight, reproductive status and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route 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

German Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Other
    • Specify - Lump
    • Symptom - Other
    • Specify - Melanoma
  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Other
    • Specify - Pulmonary disorder NOS
  • General
    • Symptom - Neoplasia

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

On approximately 01-Feb-2019, the dog developed skin lumps. On approximately 02-Feb-2019, the dog was evaluated by a veterinarian. The dog was diagnosed with melanoma and pulmonary metastasis. On approximately 21-Feb-2019, the dog died. No necropsy was performed. No further information is expected. This case is closed. Note: Previous applications were well tolerated.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Reported skin lumps are not expected after topical product application and may have numerous other causes. Melanoma along with pulmonary metastasis are not expected either after topical product application. The active ingredients are not listed as mutagenic or carcinogenic. Melanoma/metastasis needs time to develop before it can be diagnosed: likely signs were pre-existing. Other causes are more probable. Further reported death is not anticipated after product application, as inconsistent with pharmaco-toxicological product profile. However, death in this case likely associated with concomitant condition of pulmonary metastasis. Moreover, previous applications were well tolerated. No necropsy was performed. Time to onset is long (17 days and more). Considering overall aspects, a product relation is unlikely.