Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-4721
2. Registrant Information.
Registrant Reference Number: 2018EB104
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.
01-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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).
The patient is a male neutered 1,5 year old, 7,53 kg shih Tzu poodle cross. In May 2018, the pet owner applied 1 vial of K9 Advantix II medium dog topically on the pet.
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
Crossbred (Dog)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
7.53
kg
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
The patient was ok for the first 24, but became very itchy and had vomiting and diarrhea the following day. The symptoms lasted for 72 hours. Upon recommendation from the clinic, the patient was treated with warm baths, vitamin E and Benadryl. The outcome is recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
O - Unclassifiable/unassessable
Itching is not expected to be generalized but rather be linked to the application site. Other causes should be considered., e.g. allergies. Reported digestive signs are rather unspecific in dogs and may have multiple potential causes. Considering that oral uptake was not reported and rather long time to onset, a connection with the product is unassessable.