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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2430

2. Registrant Information.

Registrant Reference Number: 2018RB016

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-MAR-18

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

18-MAR-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: K9 AdvantixII 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 March 17, 2018 the pet owner applied K9 Advantix II large dog to their 4 year old, male neutered, 17 kg Shetland sheepdog that has a history of seizures every 8-9 days. The dog is also on an unknown dose of Kepra and Phenobarbital.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shetland Sheepdog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

17

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

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

11. List all symptoms

System

  • Respiratory System
    • Symptom - Panting
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
    • Specify - front legs were twitching
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Other
    • Specify - gasping for breath
  • General
    • Symptom - Other
    • Specify - laid down
  • Nervous and Muscular Systems
    • Symptom - Unconsciousness
    • Symptom - Ataxia

12. How long did the symptoms last?

<=30 min / <=30 min

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

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

His seizures had been well controlled for 3 weeks, and the day after application of K9 Advantix II large dog (March 18) he had a seizure event where he laid down, lost consciousness, was unable to walk for 20 seconds. he also was panting excessively, was gasping for breath, and his front legs were twitching prior to this event. His symptoms completely resolved within 20 minutes.


To be determined by Registrant

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

Major

19. Provide supplemental information here

N-Unlikely: 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. Moreover dog had a concomitant medical history of seizures, which may have contributed the signs. Laying down, lost consciousness, unable to walk, panting excessively, gasping for breath and front legs twitching likely associated with reported seizure. Though time to onset is consistent, considering medical history suggestive of idiopathic epilepsy, a product relation is deemed to be unlikely.