Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2624
2. Registrant Information.
Registrant Reference Number: 2018EB026
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.
30-APR-18
5. Location of incident.
Country: CANADA
Prov / State: MANITOBA
6. Date incident was first observed.
29-APR-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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 golden retriever 9 months, female, 34 kg. The pet owner applied the K9 Advantix II extra-large dog April 29th 2017 at 5 pm.
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
Golden retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.75
7. Weight (provide a range if necessary )
34
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 <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- General
- Symptom - Abnormal behaviour
- Renal System
- Symptom - Lack of control of urination
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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 vomited shortly after (food and bile) and urinated at the same time. The second time the patient vomited she seemed to be ataxic and stopped eating. The patient was brought to the emergency veterinary hospital. At the assessment at the emergency hospital, the patient was bright and alert and no ataxia was noted. The patient had not vomited since 7 pm. The patient was treated with Cerenia and Benadryl. The outcome is recovered. The patient had been drinking out of the lake and possibly out of the ditch that day.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
Reported vomiting more expected after oral uptake than after dermal application of the product. However, an oral uptake cannot be excluded. Appetite loss likely consequence of vomiting. Urination may be behavioural response to product sensation than true renal disorder. Even though more expected after oral uptake, Permethrin has the potential to cause slight neurological disorders (e.g. ataxia) in particular susceptible animals. Considering consistent time to onset, a product connection is deemed to be possible.