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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1634

2. Registrant Information.

Registrant Reference Number: 28198

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.

26-MAR-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-MAR-19

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 20-Mar-2019, a 4 year old, 11.8 kg, male neutered French Bulldog in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 2.5 ML LGE DOG, (-), by Animal owner along the dorsal midline in multiple spots. The product was used according to label (Yes).

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

French Bull Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

11.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
  • Skin
    • Symptom - Itchy skin
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Paresthesia
  • General
    • Symptom - Weakness

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

K9 advantix II large was applied on Mar 20/19. Approximately 30 minutes later became agitated, itchy, twitching skin. Bathed with Calm shampoo from vet on Mar 21/19 ~ 24 hours later. Dog was examined and no skin irritation was noted but paraesthesia. On Mar 22/19 bathed with dawn dish soap and gave dog Benedryl. Last dose of Benedryl was Mar 24/19. Dog is eating and drinking. Owner says dog seems generally weak and lethargic. Advised not a systemic product. Owner will apply vit E oil when she gets home. Dog was re-examined on Mar 27/19 and vet found nothing abnormal. Owner still complained of dog being lethargic. Outcome unknown.


To be determined by Registrant

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

Minor

19. Provide supplemental information here