Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2919

2. Registrant Information.

Registrant Reference Number: 2009TH005

Registrant Name (Full Legal Name no abbreviations): Bayer Inc.

Address: 77 Belfied Road

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.

23-MAR-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-MAR-09

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

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

5.22

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

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

11. List all symptoms

System

• Eye
  • Symptom - Other
  • Specify - bilateral corneal ulcers with perforation

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Diarrhea

• General
  • Symptom - Lethargy

• Eye
  • Symptom - Red eye
  • Symptom - Other
  • Specify - bilateral anterior uveitis with iridial involvement

• Blood
  • Symptom - Other
  • Specify - abnormal blood work results

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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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

Owner presented cat to clinic Feb 9. In poor health and severely flea infested, not doing well, was anorexic. The cat had been experiencing some diarrhea. Vaccines not current. Hadn't been eating for about a week, is very nervous. Another cat in the household died about 6 weeks ago. Cat is losing weight and losing fur and has eye discharge. Lethargy and extreme FAD were noted on exam. Mild bilateral tearing was present. Flea dirt and live fleas were observed. Caudal dorsal hair loss and dry scabbing was noted. The cat was treated with advantage, depomedrol, dex and convenia. Advantage was to be used once every two weeks for three doses. Feb 12 - the cat returned to the clinic. A FeLV/FIV test was done and routine bloodwork. ALP low 5 u/l (N 10 -90), ALT high 112 u/l (N 20-100), AMY high 1116 u/l (N 300 - 1100), Glucose high 8.4 mmol/l (N3.9-8.3), TP high 85 g/l (N54-82), globulins high 60 g/l (N15-57), MCV high 51.0 fl (N39-50), platelets low 53.0 x10exp3/ml (N200-500). No comment as to whether there was clumping. The clinic admitted the cat, placed him on IV fluids. The owner had noted the cat's eyes had changed from blue to brown. The cats skin was much improved and fleas were gone. Bilateral anterior uveitis with iridial involvement was diagnosed. No additional medication was prescribed. March 23 - cat returned to vet. Owner reports that the cats eyes get red each time they use the advantage. 4mm ulcers in each eye. Perforation of right globe. While the veterinarian does not feel this to be advantage related, they reported the event. An opthalmology consult was requested with Dr (name) Veterinary Eye Specialists. March 30 - consult with Dr (name). Dr (name) does not feel it is advantage related but cannot attribute it to other causes. Possibly herpes virus. Recommends medical treatment for left eye and conjunctival flap for right eye. Surgical repair was performed for right eye. Progress being monitored.

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To be determined by Registrant

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

Major

19. Provide supplemental information here