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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6116

2. Registrant Information.

Registrant Reference Number: 2015KP235

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd. East

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

19-OCT-15

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. 11556-152

Product Name: Advantage II Large Cat

  • 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.

.8

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 unknown date in approximately 2000, a 4 year old, male, feline, of unknown weight, reproductive status, and breed, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (cat-unspecified) (Imidacloprid) topically by the owner.From 2000 to 2010 the cat was administered 1 tube of fipronil/s.methoprene topically by the owner monthly. In 2011, the cat was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner monthly with the last dose being administered in approximately Apr 2015.

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

Other

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 )

4

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Eye
    • Symptom - Blindness (permanent)

12. How long did the symptoms last?

Unknown / Inconnu

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 approximately 06-Jun-2015, the 19 year old cat was blind, weak, and died at home. No medical intervention was sought for the clinical signs and no necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss a current flea infestation and not to report the death of the cat. No further information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported sign, blindness is not expected after product application as sign is not inline with products pharmacotoxicological profile. Other reported sign, weakness is unspecific and may have various other causes. Death is also not expected after product application as inconsistent with pharmaco-toxicological product profile. Time to onset is also not suggestive of product relation either. The cat in this case was 19 years old at the time of death, which is an upper age limit for the life span of the species. The reason for the initial phone call was to discuss a current flea infestation and not to report the death of the cat. Overall, even though some information missing (e.g. necropsy results), a product relation is considered as unlikely.