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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4528

2. Registrant Information.

Registrant Reference Number: 2013AM207

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.

13-AUG-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.       PMRA Submission No.       EPA Registration No. 11556-130

Product Name: Advantage II Extra Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PYRIPROXYFEN
      • Guarantee/concentration 44 %

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).

One vial of Advantage II extra large dog was applied topically by the owner to one spot on the dorsal midline.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Golden retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Renal System
    • Symptom - Other
    • Specify - elevated value of unspecified kidney function

12. How long did the symptoms last?

Persisted until death

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 27May2012, a then 5 year old, female, Golden Retriever, in fair condition, with a history of weak kidneys, temporary blindness, and cataracts, was administered 1 tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) once topically by the owner. On approximately 27May2013, the dog began seizuring. Bloodwork revealed an elevated value of an unspecified kidney function. As the dog was a stray, there was no previous medical history or bloodwork values to compare it with. The dog eventually passed away later that same day. The intent of the phone call to Bayer was to inquire about using the remainder of the product on a new pet, and not to report the death of the patient or any adversity with the product. 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

The information regarding the death of the dog was casually provided during an inquiry. The level of information is very low. Death occured 1 year after last product exposure therefore other etiologies have to be considered. Pre-existing kidney disorder reported and diagnosed. Nevertheless development of kidney disorder resulting in seizures and death is inconsistent with pharmaco-toxicological product profile and experience. 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. Unknown previous exposure. Finally, a product relation can be completely excluded.