Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1222

2. Registrant Information.

Registrant Reference Number: 2012BS105 - US0020979

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.

17-JUL-12

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-JUN-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. 11556-151

Product Name: advantage II Small Cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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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 June 1/2012 1 tube of Advantage II sm cat was applied topically to a 6 year old, DSH crossbred, male cat on unknown weight in good condition by owner.

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

Cat / Chat

3. Breed

DSH Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Death

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.

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 June 2/2012 the cat was lethargic, anorexic and adipsic. On June 3/2012, cat passed away of unknown causes. Unknown if necropsy performed. Cat not seen or treated by veterinarian.

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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

Lethargy and as consequence of anorexia and adipsia may occur immediately after topical application of product but not 1 day later. Unexplained death after 2 days inconsistent with pharmaco-toxicological product profile. Wide margin of safety. 4 cats in same household died on same day after showing the same symptoms (see linked cases) Therefore an intoxication or an infectious cause more likely and product relation can be excluded completely. 2012BS106 - US0020980, 2012BS107-US0020981, 2012BS108-US0020982

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

DSH Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Death

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.

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 June 2 2012 the cat was lethargic, anorexic and adipsia. On June 2 2012, cat passed away of unknown causes. Unknown if necropsy performed. Cat not seen or treated by veterinarian. No known concomitant medical conditions.

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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

Lethargy and as consequence of anorexia and adipsia may occur immediately after topical application of product but not 1 day later. Unexplained death after 2 days inconsistence with pharmaco-toxicological product profile. Wide margin of safety. 4 cats in same household died on same day after showing the same symptoms (see linked cases). Therefore an intoxication or an infectious cause more likely and product relation can be excluded completely. 2012BS105 US0020979, 2012BS107 US0020981, 2012BS108-US0020982

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

DSH Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Death

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.

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 June 2 2012 the cat was lethargic, anorexic and adipsia. On June 2 2012, cat passed away of unknown causes. Unknown if necropsy performed. Cat not see or treated by veterinarian. No known concomitant medical conditions.

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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

Lethargy and as consequence of anorexia and adipsia may occur immediately after topical application of product but not 1 day later. Unexplained death after 2 days inconsistence with pharmaco-toxicological product profile. Wide margin of safety. 4 cats in same household died on same day after showing the same symptoms (see linked cases). Therefore an intoxication or an infectious cause more likely and product relation can be excluded completely. 2012BS105 US0020979, 2012BS107 US0020981, 2012BS108-US0020982

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

DSH Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Death

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.

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 June 2 2012 the cat was lethargic, anorexic and adipsia. On June 2 2012, cat passed away of unknown causes. Unknown if necropsy performed. Cat not see or treated by veterinarian. No known concomitant medical conditions.

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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

Lethargy and as consequence of anorexia and adipsia may occur immediately after topical application of product but not 1 day later. Unexplained death after 2 days inconsistence with pharmaco-toxicological product profile. Wide margin of safety. 4 cats in same household died on same day after showing the same symptoms (see linked cases). Therefore an intoxication or an infectious cause more likely and product relation can be excluded completely. 2012BS105 US0020979, 2012BS107 US0020981, 2012BS108-US0020982