Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2005

2. Registrant Information.

Registrant Reference Number: 2013TH008

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.

22-FEB-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-FEB-13

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. 25129      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 18

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

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).

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

5.36

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Symptom - Red skin

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

Owner applied product to pet Jan 24 and Feb 19 2013. Pet had been treated with depo-medrol Jan 24 2013 for ongoing hair loss and skin issues related to eosiniphilic granuloma complex disease. Owner called Bayer Feb 22 to report she had found a bald, reddish patch of skin directly at the application site one day after application in Feb. The cat was fine after application in January. The owner feels this may have happened after use in 2009 as well. The owner washed the area the day after application with soap and water. The owner feels the area has since begun to improve and appear less red. Cat was not examined by the veterinarian. Pet was later examined by a veterinarian on Feb 27 for vomiting and diarrhea of one days duration. Owner thinks cat had worsened generalized hair loss at that time but was being treated for alopecia due to eosinophilic granuloma complex type reactions prior to use of advantage. The examining vet did not feel the application site was reddened but it was alopecic. The remained of the hair loss and the diarrhea and vomiting was not attributed to the advantage use. Medical treatment was given for the vomiting and diarrhea but not for the hair loss at the application site or the skin redness that was initially noted.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here