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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-3029

2. Registrant Information.

Registrant Reference Number: 2014CK251

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.

17-JUL-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-JUN-14

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 04-Jun-2014, a 8.5 year old, 57 pound, neutered, male, Australian Shepherd canine, in poor condition, with weight loss and pancreatitis, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) topically by the owner. The dog was also receiving an unknown dose of prednisone, an unknown dose of maropitant sodium, and an unknown dose of metronidazole to treat his concomitant medical condition. The treatment was ongoing since Feb2014.

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

Dog / Chien

3. Breed

australian shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.5

7. Weight (provide a range if necessary )

57

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Death

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 11Jun2014, one week following the application of product, the dog was found deceased by the owner. 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

Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Reliability of data is questionable due to limited information (necropsy not available). No signs of allergy/anaphylactic reaction reported. Though time to onset short, death is inconsistent with the pharmacological product profile. Animal had a history of weight loss and chronic pancreatitis for which dog was on various drugs concomitantly and the owner declined additional diagnostics to better determine the cause of the pancreatitis therefore concmomitant conditions are more likely to cause the event. Cause for death unrelated to product use. In the end, product involvement was ruled out for serious outcome and product relation considered unlikely.