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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8032

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0076053 (Report 461800)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

30-NOV-17

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

27-NOV-17

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. 11556-141

Product Name: K9 Advantix II Small 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 27-Nov-2017, a 10 year old, 7.9 pound, neutered, female, Poodle (Toy) dog,was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the animal owner.

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

Toy Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

3.583

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • Cardiovascular System
    • Symptom - Tachycardia
  • General
    • Symptom - Lethargy
    • Symptom - Death

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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 approximately 27-Nov-2017, the dog was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the animal owner. Approximately 2 hours post application, the dog exhibited shallow breathing. On approximately 28-Nov-2017, the dog exhibited lethargy and an increased heart rate. On 30-Nov-2017, the dog was examined by a veterinarian who performed unspecified radiographs with unknown results and the dog died. The veterinarian performed resuscitative efforts that were unsuccessful. No known necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Shallow breathing and further reported increased heart rate are not expected with appropriate topical product use. Lethargy is unspecific and may have numerous other causes. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction reported. Other causes are more probable in this geriatric dog. Though time to onset is consistent for initially reported signs, considering long time to onset (3 days) for death and known product safety profile, a product connection is unlikley.