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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6273

2. Registrant Information.

Registrant Reference Number: 2013CK021

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.

22-MAY-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.

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).

On 01-May-2013, a 14 year old, 140 pound, neutered, male, Mixed Breed canine, in good condition with fleas, was administered 1 tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) once topically by the owner.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cross Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

140

lbs

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 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Neoplasia
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - wasting of muscles of the head

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 22May2013 the canine was examined by a veterinarian and presented with muscle wasting on his head. Radiographs were performed and the canine was diagnosed with a carcinoma. One unknown chemotherapeutic treatment was administered. The canine was also pruritic. On 01Jun2013 the owner reapplied 1 tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) once topically on the canine. On 19Jun2013 the canine died at home. 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

The reported clinical signs, particularly detection of neoplasia and death are not expected after topical application of product as inconsistent with the pharmacological and toxicological product profile and experience. The product has a wide margin of safety and no carcinogenic potential. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. A connection between the carcinoma and the death of the geriatric dog is likely. The onset time of 3 weeks and the clinical course allow the exclusion of any product relation.