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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0710

2. Registrant Information.

Registrant Reference Number: 2015KP345

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

17-OCT-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 spot-on (Unknown)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN

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 10-Oct-2015, a 4 year old, 79 pound, neutered, male,English Bulldog/Labrador Retriever crossbred canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II(unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

English Bulldog/Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

79

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Seizure
  • General
    • Symptom - Other
    • Specify - Polydipsia
  • Renal System
    • Symptom - Inappropriate urination
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Ear
    • Symptom - Other
    • Specify - Otitis externa
  • General
    • Symptom - Neoplasia

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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 17Oct2015, the dog had a seizure, became polydipsic and began have inappropriate urination in the house. The dog had two more seizures that day. On 18Oct2015, the dog had three seizures. On 19 Oct2015, the dog presented to the veterinarian. Blood work was performed. Results were found to be within normal limits. The dog was started on a treatment regimen of diazepam 5 mg twice daily orally. From 20Oct2015 until 24Oct2015, the dog continued to have one seizure each day. On 29Oct2015, the dog had another seizure and became inappetent and adipsic. On 31Oct2015, the dog presented to the veterinarian. Upon examination the dog was circling to the right was ataxic and had otitis externa. The dog was hospitalized and started on lactated ringers solution intravenously. The dog was administered 1.8 ml of Baytril (Enrofloxacin) 100 mg/ml intramuscularly and 1 ml of chlorpromazine 25 mg/ml intramuscularly. This was extra-label use (species) of the Baytril 100. On 01Nov2015 the dog died in the hospital. A necropsy was not performed. Follow up received on 20th Nov 2015: On 13th Nov2015 a necropsy was performed. The most significant finding was extensive cellular infiltration/proliferation with rarefaction of neuropil in the mesencephalon. The pathologist diagnosed a round cell brain tumor. 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

It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological sign like ataxia, may occur even after licking. Continuation of signs argues against a product connection as well. Other causes are more probable e.g. idiopathic seizures. The other reported signs are very unspecific and may be associated with reported seizures. Otitis externa is not expected. Reported circling might be a consequence of otitis externa or seizures. Death is not expected as inconsistent with pharmaco toxicological profile of the drug. Considering unexpected signs and fatal outcome, long time to onset and chronology, and that necropsy revealed a brain tumor, a product relation is deemed to be unlikely.