Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6139

2. Registrant Information.

Registrant Reference Number: 2015KP256

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

Address: 2920 Matheson Blvd. East

City: Mississauga

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.

19-OCT-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. 11556-152

Product Name: Advantage II Large cat

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 approximately 11-Aug-2013, a 13.5 year old, neutered, male, Domestic Shorthair feline, of unknown weight, in poor condition, with concomitant medical conditions of small cell lymphoma and low white blood cell count, treated with an unspecified dose of chlorambucil since approximately Nov2011, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13.5

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Neoplasia

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?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

15. Outcome of the incident

Died

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 an unspecified date post application, in 2014, the cat exhibited weight loss. The product was re-applied on an unknown frequency with the last application on 30 Jul 2015. The cat weighed 9.2 pounds at that time. On 31 Jul 2015, the cat was lethargic and ataxic. The cat was examined by the emergency veterinarian; radiographs showed a growth in the abdomen and metastasis to the lungs. The cat was hospitalized at the emergency clinic where they had to resuscitate it on 01-Aug-2015 and on 02-Aug-2015. On 02 Aug 2015, the cat was released feeling better but not fully recovered. On 03 Aug 2015, the cat started to gradually get weaker/lethargy. On 05 Aug 2015, the cat died. Necropsy was not performed. No more information is expected. The case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported weight loss is not related to the product after the exceptional long time to onset (more than four months). Though time to onset is short for lethargy and ataxia reported on subsequent application, they may rather be related to the medical history and diagnosed metastatis. Growth in the abdomen, metastasis to the lungs and death are inconsistent with pharmacotoxicological product profile. This cat was in poor condition, with concomitant medical conditions of small cell lymphoma and low white blood cell count, being treated with an unspecified dose of chlorambucil. These factors more likely lead to the clinical signs and ultimate outcome of the patient. The product itself has no carcinogen potential. Even though necropsy is not performed considering serious outcome, a product connection is deemed to be unlikely.