Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6087

2. Registrant Information.

Registrant Reference Number: 2014CK371

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.

20-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

24-APR-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-151

Product Name: Advantage II small cat

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 an unspecified date in November of 2013, a 12 year old, 9 pound, neutered, female, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid- Pyriproxyfen) topically by the owner.

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

dsh

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

9

lbs

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
  • Symptom - Neoplasia

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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 24-Apr-2014, the cat was examined by a veterinarian and was diagnosed with an oral squamous cell carcinoma. No known treatments were performed.On 02-Jul-2014, the cat died.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

The reported signs (such as oral squamous cell carcinoma and death) are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. No signs of allergy/anaphylactic reaction reported. This was a geriatric cat suffering from underlying oral squamous cell carcinoma. The cause of death may be carcinoma. The product has no carcinogen potential thus cause for death unrelated to product use. No necropsy was performed. Time to onset is exceptionally long. In the end, product involvement was ruled out for serious outcome and deemed to be unlikely.