Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0376

2. Registrant Information.

Registrant Reference Number: 2014CK056

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.

16-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

05-DEC-13

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)

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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 %

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7. b) Type of formulation.

Liquid

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 05Dec2013, a 7 week old, 1.5 pound, intact, male, Pomeranian canine, in good condition, with fleas, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid- Permethrin-Pyriproxyfen) once topically by the owner. This was the first time of use with the product.

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

pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.14

7. Weight (provide a range if necessary )

1.5

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Approximately 1 hour post administration the dog was vomiting.On 06Decv2013 the dog continued to vomit and was examined by a veterinarian. The dog presented with muscle tremors and loose stools. He received a bath in liquid dish soap, an injection of maropitant citrate and an unknown amount of oral maropitant citrate to be administered at home.On 08Dec2013 the dog passed away at home. A necropsy was not performed.Follow-up of 19Dec2013: On 11Dec2013 a necropsy was performed by (name) Veterinary Medical Diagnostic Laboratory and the results showed mild edema in the small intestine and colon, mild reactive lymphoid hyperplasia in the spleen, mild lipadosis in the liver and mild to minimal alveolitis observed in the lung which are non-specific changes and potential causes include aspiration or acute speitcemia. However, the presence of bacteria in the lung but lack of significant inflammation is suggestive of perimortem aspiration. There are no changes suggestive of acute toxicity in this animal. No further information expected. Case closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Vomiting 1 hour after product application and later occurring loose stool rather unspecific in a young puppy however may reflect sensitive reaction to the product if oral uptake of the product cannot be ruled out. Even though more expected after oral ingestion as well, Permethrin has the potential to cause slight neurological disorders (e.g. tremors) in particular susceptible animals. Oedema, fatty liver and death not expected after product application as inconsistent with pharmaco-toxicolgocial product profile. Other causes are more probable in this 7 week old puppy, as autopsy report describes only non-specific changes which might be consequences of potential aspiration or acute septicemia. There are no changes suggestive of acute toxicity in this animal. Other potential reasons are, particularly as vaccination status at the time of product application is unknown and puppy was not examined by a veterinarian prior to the product application, i.e. acute infectious disease or consequence of the vomiting and loose stool as severe dehydration or electrolyte loss. Considering all aspects, a product connection is deemed unlikely