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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2014-1109

2. Registrant Information.

Registrant Reference Number: 2014CK002

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.

15-JAN-14

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

14-JAN-14

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).

On january 12th, 2014, Advantage 18 was applied to the back of the neck of a 1 year old male neutered (6kg) Bengal cat at a veterinary clinic.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Bengal

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

6

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Inflammation of the skin

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

2 days later the owner noted hairloss and a rash (inflammation) at the application site. The cat was taken to the veterinary clinic and received unknown medications. Update jan 23rd 2 days later (january 14th), the owner noted inflammation of the skin and hairloss at the application site. The cat was presented to the veterinarian who bathed the area, administered an antihistamine injection and prescribed Theramed topical antibiotic cream to be applied twice daily for 5 days.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Status update: Update from pet owner september 13th 2014. On September 13th 2014 called to say that the cat's fur regrew within 2 months of the initial product application. however, on an unknown date in mid september 2014, hairloss appeared on the back of the neck (at the original site of product applciation). No topical products had been applied to the cat since January 2014. A veterinarian examined the cat and reported that there was no inflammation or skin lesion other than hair loss. The veterinarian did not believe the recent hairloss could be attributed to Advantage application in January 2014. No medication was prescribed, however, the owner applied topical polysporin to the site of hairloss.