Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3232

2. Registrant Information.

Registrant Reference Number: 2013AM137

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-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

17-APR-11

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 II Large 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.

.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 partial vial of Advantage II large cat was applied topically by the owner to one spot on the dorsal midline on the queen.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Liver
  • Symptom - Elevated liver enzymes

• Renal System
  • Symptom - Other
  • Specify - elevation in kidney enzymes

• Blood
  • Symptom - Other
  • Specify - hyperlipidermia

• General
  • Symptom - Other
  • Specify - declining health

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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

Kitten #2 was nursing from a Queen who had a partial tube of Advantage ll Large Cat applied to her on 16April11 for a current flea infestation. The Queen is a stray. The Queen also had masititis. Kitten #2 had been placed on amoxicillin, an eye ointment for ocular discharge and formula (unspecified) starting on 12April11. On 17April11 the kitten appeared to be declining in health and was taken to the attending veterinarian on 18April11. Blood work on the kitten revealed an elevation in liver and kidney enzymes and hyperlipodemia. Kitten #2 died at the veterinary clinic. The attending veterinarian is suspecting a metabolic disease.

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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

If at all, only indirect exposure of puppy via treated queen to product possible. Reported signs not consistent with pharmaco-toxicological product profile. Active ingredients have wide margin of safety. Chronology not consistent either. Queen had mastitis and kitten treated with other products for various health problems concurrently. Elevated liver and renal enzymes indicate coindcidental health problems more probable cause.