Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0390

2. Registrant Information.

Registrant Reference Number: 2014CK014

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.

26-OCT-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. 11556-152

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).

On 26-Jul-2012, a 14 year old,feline, of unknown signalment, in fair condition, with concomitant medical conditions of fleas and pruritus, with a history of pyelonephritis, was administered 1 tube of Advantage 18 Topical Solution (Imidacloprid) once 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

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 )

14

7. Weight (provide a range if necessary )

Unknown

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

>2 mos <=6 mos / > 2 mois < = 6 mois

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.

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 approximately 26-Oct-2012, the cat died in its bed. No necropsy was performed.MAH comment: The information regarding the death of the cat was casually provided during an inquiry concerning product use.

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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

The information regarding the death of the cat was casually provided during an inquiry concerning product use. Reporting of occurrence more than 1 1/2 year after product application. Thus reliability questionable. Nevertheless death is not expected as inconsistent with pharmaco-toxicological productprofile and experience. Advantage is topically acting and has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24- fold overdosage tolerated by cats without showing any side effect. Death occured approximately 3 months after last product exposure, therefore inconsistent chronology. The cause of death of this cat is unknown according to case description. Medical history with pyelonephritis. No reaction on previous exposure. Allergic/anaphylactic reaction shortly after product application rather unlikely as death would have been reported at closer time following fatal outcome. The cause of death of this geriatric cat is probably related due to the renal disorder and old age. Finally, a product relation can be excluded based on time to onset and chronology