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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0101

2. Registrant Information.

Registrant Reference Number: 2013CK150

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.

06-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

26-AUG-13

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. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix 20

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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).

On 26Aug2013, a 6 year old, 18.3 kg, spayed, female, Bichon Frise canine, in good condition, with no known concomitant medical conditions, was administered 1 tube K9 Advantix 20, for dogs weighing 4.6 kilograms to 11 kilograms once topically by the owner.

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

Dog / Chien

3. Breed

Bichon Frise

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

18.3

kg

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Diarrhea
  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Hyperactivity
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Abnormal behaviour
    • Specify - licking the air

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

Within 6 hours post application the patient began panting, became hyperactive, began licking the air (behavioral), began vomiting, developed loose stools, and became pruritic. A cold compress was performed and the patient was given acetominophen, however signs continued.The patient was evaluted by a veterinarian on 04Sep2013 and no treatments were performed. Note: previous application tolerated well.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

GDS comment: Pruritus more expected to be linked to the application site than to be generalized. However, considering hyperactivity reported as well, dog may experience paresthesia caused by permethrin. Panting is not expected however is rather consequence of hyperactivity. Behavioural disorders described are very unspecific, however may be a consequence of the uncomfortable feeling caused by the applied product. Digestive tract disorders, are rather unspecific in dogs and may have multiple potential causes and are not expected following topical application of product. Potential oral uptake not reported. However, signs may be linked to hyperactivity. Considering consistent time to onset, a product connection is deemed to be possible.