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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2003

2. Registrant Information.

Registrant Reference Number: 2013TH006

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.

28-JAN-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

25-JAN-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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?

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

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

3.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Aggressive behaviour
  • Blood
    • Symptom - Hyperbilirubinemia
    • Symptom - Hypernatremia
    • Symptom - Other
    • Specify - low MCV
    • Symptom - Hyperglycemia
  • Renal System
    • Symptom - Other
    • Specify - evidence of urinary tract infection
  • Skin
    • Symptom - Hyperesthesia
    • Specify - hyperesthetic
  • Eye
    • Symptom - Pupil dilation

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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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 was given a bag of assorted tubes of advantage of different sizes. Owner applied 1 tube to length of cats back Jan 18 2013. Cat seemed fine for several days. About 3-4 days after application, the owner thought the cat was acting more aggressive than usual. The pet was presented to the veterinarian Jan 25 2013. The DVM noted the cat was hyperesthetic and over responsive to sound. Pupils were dilated but responsive. Retinas appeared normal. IV fluids were started and the cat was given 0.5 ml valium and 0.5 ml midazolam. The cat was bathed and a loose upper premolar was removed. Bloodwork showed slightly low MCV, slightly high BUN, slightly high BIL and some evidence of a UTI (3+ rods on urinalysis). The cat was started on 7 days of baytril and discharged with a note that the cat was not quite normal on Jan 26. On update Jan 28, the cat was reported to be normal again.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here