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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3070

2. Registrant Information.

Registrant Reference Number: 2013AM079

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-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-JUL-06

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. Unknown

Product Name: Advantage (Dog)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Unknown

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

1 tube of Advantage (dog-unspecified) (Imidacloprid) once topically by the owner. The tube was leaking at the time of purchase, a month prior, and the owner had placed duct tape around it and was not sure if it was cat or dog product she applied.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Staggering
    • Symptom - Ataxia
    • Specify - fell down

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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

30 minutes post application the cat fell down the stairs, was staggering, and then had a seizure. The owner then removed the duct tape and realized it was dog product. The owner contacted her veterinarian and was advised to bathe the cat, which she did. 2 days later the cat passed away. 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

Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage. From a toxicological point of view, imidacloprid or pyriproxyfen do not have potential to provoke seizures in vertebrates. In case of oral ingestion of considerable amount of product or after administration of overdose, mild neurological signs such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures and fatal not expected, as inconsistent with pharmaco-toxicological product profile. Unknown if onset time of staggering before cat fell down stairs. Seizures started after cat fell down stairs and therefore other etiologies more likely. Cat very light weight, indicating underlying disease. Though time to onset close and chronology short, product application and occurrence of signs considered merely co-incidental. Thus, overall product involvement with fatal outcome considered unlikely.