Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-2988

2. Registrant Information.

Registrant Reference Number: 2014CK210

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.

17-JUL-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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 unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %

---

7. b) Type of formulation.

Liquid

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).

On an unknown date in 2002, a 5 year old, feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (cat-unspecified) (Imidacloprid) topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

crossbreed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Erythema
  • Symptom - Pruritus

12. How long did the symptoms last?

Persisted until death

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

Died

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

On an unknown date post application in 2002, the cat exhibited erythema and generalized pruritus that was treated and resolved. Advantage application was discontinued.On an unknown date in approximately 2002, the cat was switched to a topical fipronil product. The same reaction occurred (erythema and pruritus) and the product was discontinued.On an unknown date in approximately 2002, the cat began being administered lufenuron by mouth with no known issues.On an unknown date in 2007, the cat began reacting to vaccinations. Vaccinations had to be separated and either an unknown steriod or antihistamine was administered prior to administration.On an unknown date in June 2012, the now 15 year old cat died. It is unknown if the cat was euthanized or if a necropsy was performed.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

This communication was not to report the death of the cat but to discuss product use on her current cat. Generalized pruritus and erythema are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Duration to onset time unknown. Other etiologies may be considered, eg as the same reaction occurred with other anti-flea treatment. Nevertheless, the cat died at a certain geriatric age of unknown reason but 10 years after last exposure and probably age related. A relation to the product is therefore considered unlikely.