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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6265

2. Registrant Information.

Registrant Reference Number: 2013CK013

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.

22-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. 25131      PMRA Submission No.       EPA Registration No. 11556-130

Product Name: Advantage 100

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

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 approximately 01-Jun-2011, a 8 year old, 105 pound, neutered, male, Mixed Breed canine, in good condition with no concomitant medical conditions, was administered 1 tube of Advantage 100 Topical Solution (Imidacloprid) 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 )

8

7. Weight (provide a range if necessary )

105

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Neoplasia
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 01Jul2011 the canine was examined by a veterinarian who performed magnetic resonance imagery and diagnosed him with a heart based tumor. On an unspecified date unknown anesthetics were administered and surgery was performed to remove the tumor. The canine passed away approximately 4 hours post surgery from blood loss (hemothorax). No necropsy was performed. T


To be determined by Registrant

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

Death

19. Provide supplemental information here

he owner called to determine if the product was still stable to use and if it had an expiration date, so she could return the product to her veterinarian to exchange for Advantage for her cat. The information regarding the death of the dog was casually provided during an inquiry. Heart based tumor and death are not expected, as inconsistent with pharmaco-toxicological 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. Product has no oncogenic properties. No reaction on previous exposure. The dog died after a complication to a surgical procedure according to case description. Time of death too long after last exposure. Chronology inconsistent. Finally, a product relation can be completely excluded.