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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3236

2. Registrant Information.

Registrant Reference Number: 2013AM141

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.

05-JUL-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 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).

One vial of Advantage II large 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

Domestic shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

13

lbs

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
  • Respiratory System
    • Symptom - Respiratory distress
  • Skin
    • Symptom - Cyanosis
    • Specify - cyanotic

12. How long did the symptoms last?

Persisted until death

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

Yes

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

Sunny is a 9 year old, male neutered domestic short hair weighing 13 pounds and the owner states he was in good health. Sunny's owner owns a (name) and states that Sunny has had Advantage applied in the past without consequence. On 5July11 Advantage II Large Cat was applied to Sunny for the first time. On the morning of 6July11 Sunny was found by the owner in respiratory distress. He presented to the attending veterinarian agonal, body temp of 96 no respirations and cyanotic. On ausculation the Veterinarian appreciated 2 weak heart beats and the cat died. Oxygen was administered to no avail. The owner declined a necropsy.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product has been tested at five times label dose topically and even orally with no adverse effects reported. Product has very wide margin of safety and has been proven to be nontoxic. Reported signs in particular death would not be anticipated with use of product as not consistent with pharmaco-toxicological profile. In this case oral ingestion not witnessed. Veterinary examination did not show any evidence of allergic reaction, for which fatal outcome would not be expected with topical product. Previous applications tolerated well. Most likely another underlying disease as cause. Poisoning to be considered as well.