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: 2018-6734

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0067246 (Report 533719)

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.

07-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

25-OCT-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. 11556-143

Product Name: K9advantixII large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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-Oct-2018, a 12 year old, 25 pound, neutered, female, Terrier - Boston dog, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-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

Dog / Chien

3. Breed

Boston Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

11.4

kg

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

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • 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

Immediately post-application, the dog developed lethargy, was reluctant to move, and had a decreased appetite. On 31-Oct-2018, the dog developed intermittent seizures, was evaluated by a veterinarian, however, it is unknown if treatments were performed. Approximately 1 hour post-onset of the seizures, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, more relevant specific details were not obtained nor will they be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event.


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 lethargy, reluctance to move and decreased appetite are very unspecific signs and may have varioues causes, however, time to onset is short. It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. Other causes are more likely, e.g. dog may have predisposition for idiopathic seizures. Time to onset for seizures is long. Death is not expected in dogs after product application as it is inconsistent with pharmaco-toxicological product profile. The geriatric dog likely died due to serious underlying condition. Even though time to onset is very short for initially reported signs, overall considering long time to onset (6 days) for serious unexpected signs, a product connection is unassessable.