Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2660

2. Registrant Information.

Registrant Reference Number: 2012TH006

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.

06-MAR-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-JAN-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. 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 short hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

7.51

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• Skin
  • Symptom - Red skin
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - raised areas of skin
  • Symptom - Other
  • Specify - lichenification
  • Symptom - Lesion
  • Specify - scabs - raised area of skin
  • Symptom - Pruritus
  • Symptom - Other
  • Specify - warm skin

• General
  • Symptom - Abnormal behaviour
  • Specify - self trauma

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

Cat was examined and treated with convenia Jan 2 2012. The pet was presented for licking at the hind end. Anal glands were expressed as there was swelling present under the tail. Advantage 18 was dispensed as flea dirt and scabs were present. Convenia given over right hip. Jan 16 2012 the owner called to report the cat was losing hair in some areas especially over the rump and on his chin and had started losing hair several days before. Owner was to bring in cat for an exam but couldn't catch it. Feb 28 2012 owner tried to return 3 tubes of advantage as she felt pet had a reaction. Owner called again March 6 and said area of reaction is spreading from an area starting near the base of the tail. Pet was examined March 6 2012. Evidence of self trauma on chin and dorslateral area of neck, also on dorsolumbar region, entending to tail head and medial aspect of left hind leg. The cat was very pruritic and warm to touch, affected skin is raised, red and lichenified like an eosinophilic plaque. No hair loss present at application site. Owners have also been applying tea tree oil, "healing waters" and cedar extract. After examination of pet, veterinarian does not feel reaction is related to use of advantage. A steroid injection was given to treat skin.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Moderate as treatment given