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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5694

2. Registrant Information.

Registrant Reference Number: 2018CP173

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

25-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

04-MAY-18

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII medium dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

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 May 04 2017 , a 9.4 kg, 3 year old male canine neutered Australian sheepdog , was applied one tube K9advantixII medium dog once topically by the owner;

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Australian Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

9.4

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Anxiety
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Fully Recovered / Complètement rétabli

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

a few hours after application, the dog had decreased activity , had application site itching, was hiding and had anxiety; on May 05 the dog developed loose stool; dog was treated with IV fluids, metacam and metronidazole; dog recovered on May 10 2018 ;


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Reported application site itching reflects discomfort caused by the applied product. Decreased activity and hiding are an unspecific signs and may have multiple potential other causes in a dog. However, they may represent a behavioural response to the product sensation. Anxiety is an unspefcic sign and likely a consequence of reported signs. Further reported loose stool is more expected after oral uptake than after dermal application of the product. However, considering consistent time to onset, an oral uptake cannot be excluded. Considering all aspects, a product connection is deemed to be possible.