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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3240

2. Registrant Information.

Registrant Reference Number: 2013AM145

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.

15-AUG-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. 11556-150

Product Name: Advantage II kitten

  • 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.

.23

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 kitten 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 )

15

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

Persisted until death

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

The owner applied the Advantage II for Kittens to her cat on 8/14/11. On 8/15/11 the owner noticed that the cat has seemed ataxic. The last couple of days the cat has progressively gotten worse. No treatments have been done and the cat has not been seen by the veterinarian. This was the first time use of the product. Update 22.08.2011: The owner reports that the cat was bathed on 8/17/11, however the clinical signs continued. The cat was never seen by a veterinarian, however on 8/18/11 the cat seemed really lethargic so the owner went online to a website where you could ask a vet questions. She described what was going on, however they told her that the cat needs to be seen by a veterinarian for diagnostics. On 8/19/11 the cat passed away. The cat was then taken to the veterinarian to have the body cremated. A necropsy was not 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

Ataxia and death are not expected as inconsistent with the pharmaco-toxicological product profile and experience. An appropriate dosage was applied. No oral product exposure reported. No post-mortem examination performed. However, product involvement was ruled out. Signs and outcome rather linked to underlying health problems in this geriatric cat. The technical revision of the involved batch does not reveal any deviation from the specification.