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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0698

2. Registrant Information.

Registrant Reference Number: 2015KP333

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.

15-JAN-16

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. Unknown

Product Name: advantage (unknown)

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 2001, a feline, of unknown signalment and condition, with no knownconcomitant medical conditions, was administered 1 tube of Advantage (cat-unspecified) (Imidacloprid) topically by the owner. Approximately 5 minutes post administration, the cat lickedthe application site and had a seizure and a change inbehavior. The cat was taken to a veterinary clinic andr eceived unspecified treatments.

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

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

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

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Convulsions
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Unknown

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 5 minutes post administration, the cat licked the application site and had a seizure and a change in behavior. The cat was taken to a veterinary clinic and received unspecified treatments. Approximately 1 week post administration, the cat recovered. On an unknown date in approximately 2014, the 18 year old cat passed away. It is unknown if a necropsy was performed. Limited information was provied by the reporting party as she was not calling to report the incident but had questions about product efficacy. No further information expected. Case closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Serious nervous system disorders such as seizures are not anticipated with topical use of Advantage as not consistent with its pharmacological/toxicological product profile. The application procedure and associated stress may trigger seizures in animals with a respective disposition. But that may occur with any other product. Due to oral exposure of the product, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures are not expected. Other reported behavioral sign may have occurred as consequence of seizures. Time to onset is short. However, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (14 years). Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Animal involved in this case may have died due to advanced age (18 years). Time to onset for death is also not suggestive of product relation either. Reason for initial call not to report the incident but to ask questions about product efficacy. Even though no necropsy was performed, sufficient information exists to ruled out product relation completely. Overall, a product relation considered as unlikely.