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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2757

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0026572 (Report 492494)

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.

04-JUN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

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. 11556-134

Product Name: K9 Advantix 100

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • 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 an unknown date in 2008, a 6 year old, 130 pound, neutered, male, Old English Sheep Dog canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. Follow up received on 4th Jun 2018: On an unknown date in 2008, a 6 year old, 130 pound, neutered, male, Old English Sheep Dog canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 100 (Imidacloprid-Permethrin) topically by the owner.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Old English Sheepdog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

58.967

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Other
    • Specify - Other immune system disorder NOS
    • Symptom - Death

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 an unknown date post application, in 2008, the dog was examined by a veterinarian and diagnosed with an immune mediated disease. On an unknown date post diagnosis, in 2008, the dog died at home. No known necropsy was performed. No more information is expected; this case is closed. Follow up received on 4th Jun 2018: On an unknown date post application, in 2008, the dog was examined by a veterinarian and diagnosed with an immune mediated disease. On an unknown date post diagnosis, in 2008, the dog died at home. No known necropsy was performed. No more information is expected; this case is closed. Note: The intent of the call was not to report this event but to inquire about a different product on another dog.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Immune mediated disease and further reported death are not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Very long time for reporting (10 years) as the intent of the call was not to report this event but to inquire about a different product on another dog. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Other etiologies more probable. Considering all aspects, product connection deemed to be unlikely.