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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4546

2. Registrant Information.

Registrant Reference Number: 2013AM225

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

13-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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. 11556-143

Product Name: K9 Advantix II Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

One vial of K9 Advantix II large dog was applied topically by the owner to one spot on the dorsal midline.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.5

7. Weight (provide a range if necessary )

25

lbs

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 - Death
    • Symptom - Vocalizing
    • Symptom - Abnormal behaviour
    • Specify - kicking rear legs
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Restlessness
    • Symptom - Other
    • Specify - acting slower
  • General
    • Symptom - Lethargy
    • Symptom - Swelling
    • Specify - rear legs and abdomen
    • Symptom - Fever

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 05-Mar-2013, a 8.5 year old, 25 pound, spayed, female, Shih Tzu canine, in good condition, with no known concomitant medical conditions, was administered an unknown amount of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner. One hour post application the dog was vocalizing and was kicking rear legs(behavior changes). Four hours post application the dog was vomiting and had diarrhea. The owner bathed the dog. That night approximately 8 hours post application the dog was restless. The veterinarian was consulted by phone and they advised to withhold food for 24 hours and then could offer chicken and rice for 24-48 hours after that. On 08-Mar-2013 the dog's clinical signs had all resolved expect vocalization. On approximately 13-Mar-2013 the dog was resolved of all clinical signs. No further information is expected. This case is closed. Follow-up on 25-Jun-2013: On an unspecified date in approximately Apr2013, the dog was slower acting (behavior) and needed assistance to get up on to furniture (reluctant to move). On approximately 27-May-2013 two new dogs were added to the home. They were not examined for health issues prior to introductions to this dog. On 31-May-2013 the dog was lethargic. On 01-Jun-2013 all the dogs were in the yard playing, this dog fell and could not use rear legs,and the abdomen was distended. The owner did not seek veterinary care, but gave the dog some subcutaneous fluids. This improved the dogs behavior. On 02-Jun-2013 the dog was feverish and would not move around. Still the owner did not seek veterinary care for the dog. The dog died that day. 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

Initial event, including behavioural and digestive tract disorders may be a consequence of the uncomfortable feeling caused by the applied product or unwitnessed oral product ingestion, however second episode started at least one month after administration of Advantix and are most probably related to other causes as bloated abdomen and fever are not in line with product's pharmacological profile. Death not expected either. Allergic/anaphylactic reaction unlikely due to long onset time. Although no necropsy performed, product involvement was considered rather unlikely.