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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3599

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0033131 (Report 575093)

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.

20-JUN-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. Unknown

Product Name: K9advantixII pipette size unknown

  • 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.

Unknown

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 an unspecified date in approximately 2017, a 15 pound, male, dog of unknown breed, age, or reproductive status, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in approximately 2018, the dog was administered 1 soft chew of Advantus Soft Chews (Imidacloprid) via the oral route by the animal owne

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

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

6.804

kg

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 - Neoplasia
    • Symptom - Death
    • Symptom - Parasitism
    • Specify - Fleas

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 an unspecified date in 2018, post Advantus administration, fleas were visualized on the dog. On an unspecified date in Mar-2019, the dog was evaluated by a veterinarian. The dog was diagnosed with mast cell tumors and bone marrow neoplasia and the dog died. No necropsy was performed. The intent of the call was to inquire about product use in general and not to report 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

N - Unlikely Reported mast cell tumors, bone marrow neoplasia and death are not expected in dogs, as they are inconsistent with the pharmaco-toxicological profile of the product. However, death in this case may be associated with poor underlying condition of dog. Moreover, the intent of the phone call to Bayer was to inquire about product use in general and not to report this event. Presence of fleas is not necessarily a sign of inefficacy, as product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Animal received his first pipette. Fleas were observed apparently long after product administration. Re-infestation from the environment is likely and efficacy can only be expected for a period of 4 weeks. Even though, no necropsy performed, considering long time to onset (1 year and more) for later reported signs and overall aspect, a product relation for this case is unlikely.