Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6655

2. Registrant Information.

Registrant Reference Number: 2016KP201

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-JUL-16

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. 11556-143

Product Name: k9 advantix II large dog

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

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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).

On 15-Jul-2016, a 6 year old, 80 pound, neutered, female,Siberian Husky canine, in fair condition, with a concomitant urinary tract infection, was administered a partial tube of K9Advantix II large dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was an off label use of the product as it is not intended to be applied as a partial dose.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Siberian Husky

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

80

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

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

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Other
  • Specify - Haematemesis

• Blood
  • Symptom - Anemia

12. How long did the symptoms last?

Persisted until death

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

Yes

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

On 16Jul2016 the dog exhibited anorexia and lethargy. On 23Jul2016 the dog was examined by a veterinarian, then was prescribed and administered an unspecified gastrointestinal medication. On 24Jul2016 the dog exhibited hematemesis. On 25Jul2016 the dog was transported to another veterinarian. Unspecified blood work was completed. Results indicated the dog was anemic. Prednisone and antibiotics were prescribed and administered to the dog who was released from the clinic. The dog died on 25Jul2016. The veterinarian suspected the dog may have died from anemia caused by flea infestation. A necropsy was not performed. No further information is expected. This case is 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

Reported anorexia and lethargy are unspecific signs and may have numerous other causes in dog. Hematemesis, anemia and further reported death are not expected as inconsistent with pharmaco-toxicological product profile. Death likely linked to a severe underlying condition reflected by anemia (e.g. internal hemorrhage). No necropsy performed. Though serious sign is reported, considering consistent time to onset for first course of signs and no diagnosis made, a product connection is unassessable. Dog was applied with a too low dose of the product, thus the labeled efficacy of the product cannot be guaranteed. Moreover the vet mentioned flea infestation but no fleas were reported. Therefore a lack of efficacy cannot be considered.