Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-4929

2. Registrant Information.

Registrant Reference Number: 2011TH068

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.

21-SEP-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-MAY-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)

---

PMRA Registration No. 25129      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 18

• Active Ingredient(s)
  • IMIDACLOPRID

---

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).

Advantage 18 is too large a dose for this cat

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Medium Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

2.7

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

• Nervous and Muscular Systems
  • Symptom - Seizure

12. How long did the symptoms last?

<=30 min / <=30 min

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

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

Cat was prescribed advantage Oct 14 2010 and Sept 6 2011. Owner contacted clinic Sept 9 to advise cat had what owner reported to be a seizure (cat in lateral recumbency and twitching for about 30 seconds) after advantage use in May and 2 days after advantage use in September (applied sept 6, seizure noted sept 8. Owner not sure how long seizure was noted after advantage use in May, would have been days. Cat has not seizured on any other occasions and has not been diagnosed with a seizure disorder. Cat used advantage in Sept and Oct of 2010 with no reports of seizures. Pet was examined Sept 9 2011 but no abnormal findings were observed and bloodwork collected was normal. No treatment was given.

---

To be determined by Registrant

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

Major

19. Provide supplemental information here