Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5549

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0057770 (Report 524062)

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.

26-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

25-SEP-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.       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 25-Sep-2018, a 2 year old, 13 pound, neutered, male, Domestic (Unspecified) cat, in unknown condition, with no known concomitant medical conditions, was administered 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic (Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

5.897

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Eyes rolling back
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Approximately 3 hours post application, the cat developed shaking. Approximately 4 hours post application, the cat developed a seizure, hypersalivaton, and eyes rolling back. Approximately 1 minute after onset of clinical signs, the seizure, hypersalivation, and rolling back eyes stopped, and the saking continued. Approximately 12 hours post application, the cat died. The cat was not examined by the veterinarian. It is unkown if a necropsy has been performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported shaking is not expected and may have multiple potential other causes in an animal. In this case sign likely associated with onset of later reported seizure. Serious nervous system disorders such as seizure is not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizure in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizure is not expected. 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. Other causes must be considered. Hypersalivation and eyes rolling back are likely secondary to seizure. Further reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile and likely consequence of seizure. a lot of Information not available (e.g. necropsy and animal details), thus considering all aspects and short time to onset , a product relation is unassessable.