Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3251

2. Registrant Information.

Registrant Reference Number: 2013AM156

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.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

22-OCT-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage II

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

---

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).

One vial of Advantage II was applied topically by the owner to one spot on the dorsal midline.

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

unknown

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy
  • Symptom - Vocalizing
  • Symptom - Hiding

• Nervous and Muscular Systems
  • Symptom - Seizure

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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

Owner reports his cat was lethargic and vocalizing from a heavy flea infestation. Caller bathed cat with Hartz Flea and Tick shampoo on 10-22-11. The caller then placed cat in carrier and put in his car while he set off flea bombs in house and took laundry to laundromat. Caller returned home, applied product to cat and within 2 minutes the cat was hiding behind door, then vocalized, had a siezure and died. Caller reports no exam/necropsy were performed. No further information expected.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Serious nervous system disorders such as seizures and fatal outcome not anticipated with topical use of Advantage, as inconsistent with its pharmaco-toxicological profile. Cat heavily infested with fleas. Flea and tick shamppo used on cat which may contain pyrethroids. Furthermore containment stress and household flea bomb may have aggrevated situation. No signs of allergic /anaphalyctic reaction nor oral ingestion of Advantage reported. Time to onset too short for an product resorption. Even though no necropsy result available, overall, connection with Advantage considered unlikely. More probably effect of other applied products or underlying medical problem.