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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4510

2. Registrant Information.

Registrant Reference Number: 2013TH132

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.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


PMRA Registration No. 27659      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 100

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?


Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms


  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Drooling
  • General
    • Symptom - Fever
  • Gastrointestinal System
    • Symptom - Stomach pain
    • Symptom - Other
    • Specify - delayed gastric emptying
  • Blood
    • Symptom - Hyperbilirubinemia
    • Symptom - Leukopenia
    • Specify - neutropenia
  • Renal System
    • Symptom - Other
    • Specify - urinary tract infection
  • General
    • Symptom - Other
    • Specify - uncomfortable in her cranial abdomen

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

13. Was medical treatment provided? Provide details in question 17.


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

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

Owner applied product Aug 1 2013. Owner called clinic Aug 6 2013 to report that Lily seemed lethargic starting Aug 2, was better Aug 3 and was lethargic and drooling Aug 6. Pet was examined Aug 6 and lethargy, drooling and a loss of appetite was noted. Temp was 39.6 and the dog may have been uncomfortable in her cranial abdomen. Bloodwork and radiographs were unremarkable except for lots of food noted in the stomach and a mild neutropenia and mild elevation in bilirubin. Delayed gastric emptying was suspected. A few white blood cells were noted on urinalysis so a urinary tract infection was also deemed possible. Sucralfate, famotidine and Clavaseptin were prescribed. Owner decided to get ultrasound done on Aug 8 (DVM didnt recommend). Repeat bloodwork at OVC was normal and ultrasound was unremarkable. Dog was recovered Aug 12 2013. Dog regularly attends doggie daycare. Owner feels dog may have been lethargic for one day after July application. Neither veterinarian feels this reaction was product related.

To be determined by Registrant

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


19. Provide supplemental information here