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: 2018-0448

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0076646 (Report 462611)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

05-DEC-17

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. 11556-155

Product Name: Seresto unspecified

  • Active Ingredient(s)
    • FLUMETHRIN
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

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 01 Sep 2017, a male Canine, of unknown signalment and condition, with no known concomitant medical conditions, had 1 Seresto (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

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 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Regurgitation

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

Yes

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 unknown date in Oct 2017, the dog had seizures and vomiting. On an unknown date in Oct 2017, the dog was examined by a veterinarian, had bloodwork done, including testing for Addison's disease, which was negative. The dog was placed on a prescription diet. It is unknown if any other treatments or procedures were performed. On an unknown date in Oct 2017, the clinical sign of vomiting resolved. On an unknown date in approximately Nov 2017, the dog began to cough and have regurgitation. On 02 Dec 2017, the dog died. No known necropsy was performed. No more information is expected. This case is closed. This report was received via social media post and specific relevant event details were limited.


To be determined by Registrant

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

Death

19. Provide supplemental information here

O-Unassessable: The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Vomiting is very unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Coughing is not expected following collar application. Regurgitation is unspecific and not expected, however, may be associated with reported coughing. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Other causes are more probable. Time to onset not consistent as approx. one month. Root cause for coughing and regurgitation and death unknown. Although not deemed product related, due to limited information, the case was considered as unassessable.