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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3788

2. Registrant Information.

Registrant Reference Number: 2012TH089

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.

03-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

25-JUN-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. 25132      PMRA Submission No.       EPA Registration No.

Product Name: advantage 20

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

6.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Weight loss
    • Symptom - Vomiting
  • Renal System
    • Symptom - Creatinine increased
  • Blood
    • Symptom - Other
    • Specify - albumin increased
  • General
    • Symptom - Dehydration
    • Specify - mild dehydration
  • Blood
    • Symptom - Thrombocytopenia
    • Specify - decreased platelets
    • Symptom - Other
    • Specify - Increased HCT

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

Pet owner treated pet sometime in June with advantage 20. The date is unknown. June 27 the owner presented the pet to the clinic as the dog had not eaten well in 3 days and vomited once. The differential diagnosis was viral or parasitic gastroenteritis, pancreatitis and dietary indescretion. Bloodwork was done that showed increase HCT and decreased platelets but clumping was present. Albumin was increased, ALP was decreased and creatinine was increased. A SNAP cPLi was negative. Mild dehydration was noted. A radiograph was recommended and the owner declined. Pepcid was prescribed.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here