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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0503

2. Registrant Information.

Registrant Reference Number: 2015CK011

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.

19-JAN-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-AUG-08

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: k9 advantix (unknown)

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

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).

On 01-Aug-2008, a 10 year old, 9 pound, intact, male, Papillon, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid-Permethrin) 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

paillon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

9

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 / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Fever
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Seizure

12. How long did the symptoms last?

Unknown / Inconnu

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

During application, the dog struggled; this resolved immediately post application.Approximately 2 hours post application, the dog had vomiting, diarrhea, pyrexia, anorexia and lethargy.On approximately 07-Aug-2008, the vomiting, pyrexia, diarrhea and anorexia resolved without medical intervention but the dog continued to be lethargic. The owner ceased use of the product. No medical attention was sought.On an unspecified date in Jul-2012, the dog had seizures and then died. No medical attention was sought and 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

Behavioural disorder such as struggling described very unspecific. However, may due to restraint, as the dog recovered immediately post application. Digestive disorders such as vomiting and diarrhea are more expected after oral uptake, which is not reported. Pyrexia is unexpected and may have various infectious causes. Lethargy and anorexia are very unspecific signs and may be a consequence of other signs reported. However all non-serious signs resolved within a few days.Serious signs such as seizures and fatal outcome are not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Furthermore time to onset of about four years for serious sign and fatal outcome is much too long. Overall even level of information is low e.g. age, medical history and necropsy not performed, considering time to onset of predominant serious signs a product connection is deemed to be unlikely.