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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3620

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0027018 (Report 708958)

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.

22-JUN-21

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

10-JUN-21

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 08-Jun-2021, a 13 year old, of unknown weight, male, Shepherd Dog - German dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Over 55 lbs) (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 )

13

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Pain
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Ataxia

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On approximately 10-Jun-2021, the dog developed pain and ataxia. On approximately 11-Jun-2021, the dog died. No necropsy was 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

O - Unclassifiable/unassessable Even though more expected after oral uptake, permethrin has the potential to cause mild, transient neurological disorders such as ataxia in particularly susceptible animals. Pain is not expected after topical application of the product. Other causes should be considered. Further reported death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Time to onset is long (2 days and more). Other causes should be considered in this geriatric dog. Considering all aspect, a product connection is unassessable.