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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4451

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0038877 (Report 581290)

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.

11-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-JUL-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. 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 10-Jul-2019, a 12 month old, 5 pound, intact, male, cat, in unknown condition, with no known concomitant medical condition was secondarily exposed to a dog that had K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) applied on 10-July-2019 in the same household. The dog was not separated from the cat post product application to the dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

2.26

kg

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Drooling

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?

Other / Autre

specify cat, in unknown condition, with no known concomitant medical condition was secondarily exposed to a dog that had K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) applied

17. Provide any additional details about the incident

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

On 11-Jul-2019 the cat exhibited hypersalivation, seizures both for approximately 2 hours and then died. The cat was not examined by a veterinarian and a necropsy was not performed. 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

A - Probable Off-label use (unauthorised species). Reported seizure and hypersalivation and time to onset is consistent with permethrin toxicity in cats. With timely and intensive treatment, death is usually preventable. Considering consistent time to onset, a product relation is probable.