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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6275

2. Registrant Information.

Registrant Reference Number: 2013CK023

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

18-JUL-13

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. 11556-130

Product Name: Advantage II Extra Large Dog

  • 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.

Unknown

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 approximately 25Apr2013, an approximately 5.5 year old, 10 pound, spayed, female, Domestic Shorthair feline, in good condition with no concomitant medical conditions, was administered a partial tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) once topically by the owner. This is an off-label use of the product. The owner continued to treat the feline every 4 weeks in the same way. On approximately 15May2013 the feline was scratching at her ears. The owner treated the cat with an over-the-counter ear cleanser. On 18Jul2013 the owner administered a partial tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) once topically as she had been every 4 weeks.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Short Hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

The owner left the home and returned approximately 6 hours later to find the feline dead. No clinical signs occurred prior to death. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Intentional misused direct topical dermal exposure of the product to the cat. Exposed site is inconsistent with affected site. Sudden death is inconsistent with pharmacotoxicological product profile and experience. 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. The cause of death of this cat is unknown according to case description. No reaction on previous misused exposures even not to the other cats in the household treated this way. No signs of allergic/anaphylactic reaction reported. However, short onset time after last application. Based on current knowledge and without veterinary necropsy is a reliable causality assessment not possible.