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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6749

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0069159 (Report 535631)

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.

19-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-OCT-18

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).

On approximately 29-Oct-2018, a 10 year old, 13 pound, intact, male, Pomeranian canine, in unknown condition, with no known concomitant medical conditions, was administered a partial tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was an off label use as the product is not labelled to be administered in this manner.

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

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

5.897

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Coughing
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - Recumbency
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Other
    • Specify - Behavioural disorder NOS

12. How long did the symptoms last?

Persisted until death

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

Approximately 6 hours post application, the dog was coughing and was bathed in an unspecified type of shampoo. On approximately 31-Oct-2018, the dog was lethargic. On approximately 1-Nov-2018, the dog was anorexic, had a behavior disorder NOS and was recumbent. No medical treatment was sought. On approximately 2-Nov-2018, the dog was bathed again in an unspecified type of shampoo. On approximately 4-Nov-2018, the dog died and no necropsy was performed. No further information is expected. The 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 coughing is not expected after topical product application and may have multiple potential causes. Later reported lethargy and behavioural disorder are unspecific signs and may have numerous other causes. Anorexia may be associated with reported lethargic status. Recumbency and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Other causes should be considered in this geriatric dog. Though time to onset is short for coughing, considering long time to onset (2 days and more) for later reported signs and low level of information (medical history and necropsy details are not available), a product connection is unassessable.