Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-4351
2. Registrant Information.
Registrant Reference Number: 2018RB053
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.
22-MAY-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
06-MAY-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).
On May 6, 2018 the pet owner applied K9 Advantix II extra large to their 25.8 kg, female neutered, 2 year old crossbred dog.
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
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
25.8
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Skin
- Symptom - Itchy skin
- Symptom - Pruritus
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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 dog had a behavior change and was rubbing the application sites after application, and became itchy. Two days later the dog was seen by a veterinarian for vomiting, itchiness, and change in behavior. The veterinarian recommended bathing with detergent and vitamin E application to the application sites. On May 14, 2018 the dog returned to the veterinarian for diarrhea and continued behavior change and bloodwork was performed, which was normal. The dog was placed on antibiotics and 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. Moreover, sign along with reported application site rubbing reflects discomfort caused by the applied product. Behaviour change and later reported vomiting, diarrhoea are very unspecific and may have numerous other potential causes. Though time to onset is consistent for initial signs, considering rather long time to onset ( 2 days), a product connection is unassessable.