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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3246

2. Registrant Information.

Registrant Reference Number: 2013AM151

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.

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 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.

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 extra large 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 )

10

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
  • Blood
    • Symptom - Anemia

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 unspecified date owner applied a partial tube or Advantage II Extra Large Dog to a 10 year old feline. Unspecified date this feline had neruologic signs. Unspecified date owner took to a veterinarian who treated with subcutaneous fluids "to prevent neurologic sxs". The next day the cat was taken to another clinic. Vet bathed cat with Dawn, which seemed to help and put this feline on methocarbamol which made this feline worse. The feline was having difficulty walking while on the methocarbamol. Owner states this feline needed to be flushed internally with intravenous fluids but the vet did not want to overload this feline with fluids as she thought that this feline had a heart murmur and because this feline had fluids the night before. According to second vet, cat was tremoring. Updated information 24.10.2011: This feline was not able to eat while on the methocarbamol. Hematocrit was 20-22 per what the owner remembers. On approximately 10Oct2011 this feline died and was found to be positive for FIV (Feline immunodeficiency virus) and very anemic. No necropsy examination was performed. No more information expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product used off-label as partial tube of product intended for dogs used on cat. This feline had an ongoing heavy flea infestation and was anaemic and FIV positive. Active ingredients of Advantage II Extra Large Dog topically acting only. Heavy flea infestation can be contributing factor to anemia. Cardiac signs inconsistent with pharmacotoxicological product profile. Most likely cat died due to underlying disease (e.g. cardiac disorder) and/or FIV infection.