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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5464

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0044536 (Report 510430)

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.

06-AUG-18

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

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.

Other (specify)

spot on

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 an unknown date in approximately 2016, a 5 year old, 5 pound, neutered, female, Egyptian Mau cat, in unknown condition, with no known concomitant medical conditions, was administered an 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Egyptian Mau

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

2.268

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Eye
    • Symptom - Other
    • Specify - Bulging eye
  • General
    • Symptom - Cancer
    • Symptom - Death

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

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 undetermined date post product application, in approximately 2016, the cat developed lymphoma, eye bulging and died. No necropsy was performed. Due to the sensitive nature of the communication, certain relevant details were not obtained, nor will such be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event. No further information is expected. This 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

N - Unlikely Reported lymphoma, bulging eye and subsequent death are not expected not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Moreover, the reason for the initial phone call was to discuss use of the product and not to report the death in this event. In case of suspected product involvement case would have been reported in close proximity and not after long time (almost 2 years). Even though some information (e.g. time to onset, necropsy results) is not available, considering the known product profile and intent of call, a product involvement is deemed to be unlikely.