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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5271

2. Registrant Information.

Registrant Reference Number: 2018TH053

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.

12-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-JUN-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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII extra large dog

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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 12-Jun-2018, an 8 year old, 83.8 pound, neutered, female, Retriever Labrador (No Description) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) for dogs over 25kg topically by the owner. Note: Product used was Advantix plus spot on 4.0 ml.

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

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

38

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 - Pruritus
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Other
    • Specify - Tenesmus
    • Symptom - Bloody stool
    • Specify - Haematochezia

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

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

Approximately 9 hours post application, the dog exhibited licking and had diarrhea twice. The licking resolved in approximately 5 minutes. Approximately 9.5 hours post application, the owner took the dog for a walk and the dog exhibited tenesmus, straining to defecate and hematochezia. The dog was not examined by a veterinarian and the clinical signs continued.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported licking is not expected after topical product application and may have numerous other causes. Diarrhoea is an unspecific sign and may have numerous other causes. Tenesmus and straining to defecate are not expected either. However, in this case signs may be associated with reported diarrhoea. Haematochezia is not expected even after ingestion, as inconsistent with pharmaco-toxicological product profile. However, sign rather argue for infectious cause or foreign body. Though time to onset is consistent, considering all aspects, a product connection is unassessable.