Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-4088
2. Registrant Information.
Registrant Reference Number: 2018RB100
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.
18-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-JUN-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. Unknown
Product Name: K9advantixII pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
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 June 16, 2018 the pet owner applied an unknown dose of K9 Advantix II to their 10 year old American Husky dog.
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
American Husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Recumbent
- Symptom - Muscle tremors
- Symptom - Seizure
- General
- Symptom - Death
- Symptom - Vocalizing
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
The dog was fine the day of application, but the following day the dog was found recumbent and tremoring. The dog was vocalizing and had respiratory difficulty, then had a seizure. The pet owner did not seek immediate veterinary care and the dog died 30 minutes later.
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
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. tremoring may occur even after oral uptake. No oral exposure reported. Vocalisation, recumbency and respiratory difficulty may rather be linked to seizure. Death is not expected either. No signs of allergy/anaphylactic reaction reported. Other causes should be considered in this geriatric dog. Even though time to onset is consistent, considering overall aspects, a product relation is unassessable.