Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4576

2. Registrant Information.

Registrant Reference Number: 2013AM193

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-AUG-13

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)

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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 8.8 %
  • PYRIPROXYFEN
    • Guarantee/concentration 44 %

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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).

One vial of Advantage II small cat 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

Ragdoll

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

7

lbs

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

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Weakness

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

On 18Apr2013, a 10 year old, 7.00 pound, spayed, female, Ragdoll feline, in fair condition, with dyspnea,was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) once topically by the owner. This was the first time of use of the product. Immediately after application the cat was ataxic. Approximately 8 hours after application the cat recovered from the ataxia but was weak. The cat was not examined by a veterinarian and medical treatments were not performed. On 20Apr2013 the cat was found deceased. It is unknown if a necropsy was performed.

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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

Ataxia is not typically observed with appropriate topical product administration, however is possible with oral product exposure or administration of an overdose. But as onset time very short, ataxia and weakness may be a mere behavioural response to the product sensation. Fatal outcome not expected after correct product application. Even with administration of an overdose or oral exposure - although not reported - death not expected. Animal was in fair condition and suffered from dyspnoea prior to treatment. Signs rather due to underlying undiagnosed condition of the cat. A product relation is deemed to be unlikely.