Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4555

2. Registrant Information.

Registrant Reference Number: 2013AM174

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.

13-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. 11556-118

Product Name: Advantage 18

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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).

One vial of Advantage 18 was applied topically by the owner to one spot on the dorsal midline.

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

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

On an unknown date, a feline of unknown signalment, in poor condition that was geriatric and had an unknown bladder issue, was administered 1 tube of Advantage 18 Topical Solution (Imidacloprid) once topically by the owner. On an unknown date in approximately 2011 the cat passed away. It was unknown if a necropsy was 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

Information regarding death of cat casually provided during inquiry on expiration of product. Report lacks important information (e.g. patient details, date of exposure, time to onset, description of signs etc.). However, occurrence of fatal outcome probably not within close time of product application. Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset and chronology unknown. Reporting of occurrence over two years after product application and fatal outcome makes reliability of report questionable. Other underlying medical issues (history with urinary tract disorder reported) and age of cat more likely cause for fatal outcome. Therefore, inspite of lack of information product relation considered unlikely.