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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4034

2. Registrant Information.

Registrant Reference Number: 2015KP151

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

Address: 2920 Matheson Blvd. East

City: Toronto

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.

20-JUL-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

05-JUN-15

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. Unknown

Product Name: k9 advantix II unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 05-Jun-2015, an 8 month old, 30 pound, intact, female, German Shepherd Dog canine, in an unknown condition with a concomitant medical condition of fleas, was administered an a partial tube of K9 Advantix II (unspecified) (Imidacloprid- Permethrin-Pyriproxyfen) topically by the owner. I

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.8

7. Weight (provide a range if necessary )

30

lbs

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Drooling
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Diarrhea

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

Immediately post application the dog was drooling and lethargic. At an unspecified time post application the dog had bloody diarrhea. On 7-Jun-2015 the dog died. No necropsy was performed. No further information is expected, 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

Reported drooling and lethargy are unspecific signs and may have multiple potential other causes in a dog. Even after ingestion, bloody diarrhea is not expected after product application. Described course and sign rather argue for an infectious cause or foreign body. Death is also not expected in dog after product application, as it is inconsistent with the pharmaco-toxicological product profile. Even though low level of information regarding pipette size, state of health, condition of dog, medical history and necropsy not performed are available, considering the juvenile status of the animal, other etiologies are more probable. No signs of allergy/anaphylactic reaction reported. Finally, even though time to onset for initial signs was short, considering overall aspects, a product relation is deemed to be unlikely.