Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0924

2. Registrant Information.

Registrant Reference Number: 2012BS237 - US0042543

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.

19-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-SEP-12

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. 11556-144

Product Name: K9advantix II Extra Large 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 September 15/2012, 1 tube of k9 advantix II extra large dog was applied topically by owner to a 9 year old, 80 lb, neutered male Golden Retriever for a current flea infestation.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

80

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Inappropriate defecation
  • Specify - Involuntary defecation
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Decreased pulmonary function
  • Specify - respiratory depression

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Collapse

12. How long did the symptoms last?

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

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

On Sept 16/2012, the dog was running and playing at the beach when he collapsed suddenly. After the collapse, dog's respirations were very shallow. The dog was taken home and when he tried to stand he was ataxic and collapsed again. He then proceeded to try to crawl, began to vomit. He had 2 episodes of vomiting, defecated and then passed away. Event took approximately 1.5 hours. No necropsy performed.

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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

Complained batch was manufactured and released with no deviations. No deviations related to complaint. Death not expected following product application. No localized edema at application site or facial edema reported. No previous exposure. Thus no indicative signs of allergic/anaphylactic reaction to product (time to onset 24 hours). Dog had history of flea allergy dermatitis and food allergy. More probable patient ingested something at the beach which lead to reaction or possible insect bite or possible over-exercise of dog at beach and resulting circulatory disorder. No necropsy available and time of onset short, case remains unassessable.