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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3097

2. Registrant Information.

Registrant Reference Number: 2013AM097

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.


Prov / State: UNKNOWN

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.       PMRA Submission No.       EPA Registration No. 11556-128

Product Name: Advantage II Small dog

  • Active Ingredient(s)
      • Guarantee/concentration 9.1 %
      • Guarantee/concentration .46 %

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).

One vial of Advantage II Small dog was applied topically by the owner to one spot on the dorsal midline.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed


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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms


  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Difficulty Breathing
    • Symptom -
    • Specify - Chronic obstructive pulmonary disease
  • General
    • Symptom - Listless
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
    • Specify - soft stool
  • General
    • Symptom - Discomfort
    • Specify - uncomfortable
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • Respiratory System
    • Symptom - Respiratory distress
  • Gastrointestinal System
    • Symptom - Other
    • Specify - hemorrhagic enteritis
  • Cardiovascular System
    • Symptom - Other
    • Specify - enlarged heart
  • General
    • Symptom - Other
    • Specify - adrenal gland tumor

12. How long did the symptoms last?

Persisted until death

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


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

On approximately 01-Jan-2010 a 10 year old, unknown weight, spayed, female, Maltese canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Adavntage (dog unspecified) once topically by the owner. The owner continued to apply the product on an unknown basis yearly. On approximately 01-Mar-2010 the dog had difficulty breathing. The dog was examined by the veterinarian and diagnosed with Chronic obstructive pulmonary disease. The veterinarian prescribed an unknown dose of prednisone and an unknown dose of theophylline at that time. These treatments were used as needed. On 07-Nov-2012 the patient was administered an unknown amount of moxidectin injectable by the attending vet. On 15-Jan-2013 the dog was administered a distemper/parvo vaccination, a lepto vaccination, and a flu vaccination by the attending vet, and was prescribed neomycin/polymyxin B/dexamethasone drops to be applied to the eyes for conjunctivitis. The dog was also administered 1 tube of Advantage II Smal Dog (Imidacloprid-Pyrifroxyfen) once topically by the owner. On 16-Jan-2013 the dog was listless, vomiting, and had soft stool. The owner contacted the veterinarian who advised that the dog be examined but the owner declined. 2 hours later the owner contacted the veterinarian and adivsed that the dog was uncomfortable and again declined an exam. 3 hours later the owner called and advised bloody diarrhea and wanted to wait until the next morning to have her examined. On 17-Jan-2013 the dog was examined by the veterinarian. Radiographs showed a dense mass cranial to the right kidney and excess gas in the intra-intestinal area. A fecal was performed and was negative. 20 minutes later the dog collapsed with respiratory distress. The veterinarian administered .5cc of doxapram intramuscular and .3cc of epinephrine intramuscular. The dog was intubated. 5 minutes later the dog passed away. On gross necropsy performed by the veterinarian the dog was found to have hemorrhagic enteritis, an enlarged heart, and an adrenal gland tumor.

To be determined by Registrant

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


19. Provide supplemental information here

Reported signs and fatal outcome not expected after topical application of Advantage, as inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 20- fold overdosage tolerated by dogs without showing any side effect. Product used on animal before without causing any signs. Though time to onset appears close, chronology and prior health status of dog also argue against product relation. Necropsy revealed hemorrhagic enteritis, enlarged heart, and adrenal gland tumour. Finally, product relation can be completely excluded.