Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5712
2. Registrant Information.
Registrant Reference Number: 2018EB140
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.
13-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
07-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).
The patient is a 10 year old, male neutered 32,7 kg, Rottweiler Doberman cross. On May 5th, the pet owner applied 1 vial of K9 Advantix II extra-large 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
Male
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
32.7
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Symptom - Lesion
12. How long did the symptoms last?
Unknown / Inconnu
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
Unknown/Inconnu
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
Within a few days, the patient became very itchy and developed skin lesions all over his body. The patient was not treated. The pet owner reapplied 1 vial on June 6th. Within a few days, the same clinical signs appeared. The patient was seen at the clinic on June 13th lesions were still present on the right cheek and the left leg and the patient was treated with cefaseptin and prednisone.
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
Reported itchy skin is not expected to be generalised but rather be linked to the application site. Other causes should be considered, e.g. allergies, parasites. Skin lesion is not expected either, in this case may be associated with reported itchy skin. Considering a bit long time to onset (2 days) and signs reappear on further application,a product connection is unassessable.