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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6277

2. Registrant Information.

Registrant Reference Number: 2013CK025

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.

12-APR-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. 11556-127

Product Name: Advantage II 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.

2.5

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 approximately 01-Feb-2011, a 10 year old, 52 pound, spayed, female, Chowchow Mix canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II 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

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

52

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
  • Liver
    • Symptom - Elevated liver enzymes
  • Gastrointestinal System
    • Symptom - Loss of appetite

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Unknown

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

An unspecified amount of time after application, the patient had a torn cruciate ligament. An unspecified amount of time later, the patient had surgery and had the ligament repaired. The patient was on exercise rest for 8 weeks following. On approximately 10-Apr-2011, the owner gave the patient a chicken treat. Approximately 8 hours later, the patient would not eat. On approximately 11-Apr-2011, the patient was taken to the veterinary clinic where they performed blood work, revealing elevated liver values. On approximately 12-Apr-2011, the patient died. It is not known whether or not a 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

Reporting of occurrence two years after product applicationn and occurrence of fatal outcome. Cruciate ligament rupture at unknown time after product application not expected as inconsistent with pharmaco-toxici logical product profile. This has rather traumatic causes. Time to onset between not eating or elevated liver enzymes and last product exposure is more than two months. Unknown dog treat was given prior to onset of signs. Both signs not expected. Death also notexpected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Long time to onset, chronology and signs argue against product relation. Hepatic disorder as underlying cause and old age most likely cause of death. Therefore, a product relation is considered unlikely.