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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6288

2. Registrant Information.

Registrant Reference Number: 2013CK032

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.

01-DEC-12

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-Jun-2012, a 16 year old, 50 pound, neutered, male, Mixed Breed canine, in good condition with no 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

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

50

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

>6 mos / > 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Other
    • Specify - pancreatitis

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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 approximately 01Dec2012 the canine was examined by a veterinarian and was diagnosed with pancreatitis. On an unspecified date during December of 2012 the canine weighed approximately 20 pounds and died. It is unknown if a necropsy was performed. The owner called to inquire if the product had an expiration date because she wanted to use it on another pet and understood that the death of her dog was not product related. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The information regarding the death of the dog was casually provided during an inquiry. Pancreatitis, resulting in weight loss and death not expected, as inconsistent with pharmacotoxicological product profile and experience. Product is only topically acting and has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. No reaction on previous exposure. Clinical signs and death occurred one half year after last product exposure. Thus time to onset and chronology also argue against product relation and other etiologies (underlying medical condition, age) more likely in this old dog. Finally, a product relation can be completely excluded.