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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6644

2. Registrant Information.

Registrant Reference Number: 2018RB147

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.

20-AUG-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-AUG-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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

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 19-Aug-2018, an 8 year old, 12 pound, male, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was administered K9 Advantix II Large Dog 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

5.443

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Head shaking
    • Symptom - Muscle tremors
  • General
    • Symptom - Fever

12. How long did the symptoms last?

Unknown / Inconnu

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

Fully Recovered / Complètement rétabli

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 20-Aug-2018, the cat developed dyspnea. The cat was not seen by the veterinarian, no treatments were performed, and the clinical sign continued. This case was reported to veterinary scientific affairs Canada August 21, 2018. The cat presented to the veterinarian and displayed headshaking, tremors, and was pyrexic. The cat was also ataxic. The cat was bathed and started on IV fluids, methocarbamol, and valium. The cat recovered on an unknown date.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible - Off-label Use (unauthorized species). Reported dyspnoea is not expected with appropriate topical product use. It may rather be a behavioural reaction to product sensation than a sign of respiratory illness. Further reported tremors and ataxia are consistent with permethrin toxicity following direct product use on a cat. Pyrexia may be associated with excessive muscle activity. Head shaking is an unspecific sign. However, it may be associated with reported neurological signs. Considering consistent time to onset, a product connection is deemed to be possible.