Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2455
2. Registrant Information.
Registrant Reference Number: 2018CK010
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-APR-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix II 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).
11yr mn golden doodle 34.2kg treated with k9 advantix II XL on multiple occasions in 2017. The most recent application was in November 2017.
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 )
11
7. Weight (provide a range if necessary )
34.2
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Symptom - Other
- Specify - Seborrhoea
- Symptom - Other
- Specify - Application site pigmentation disorders
- Symptom - Hair loss
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
The most recent application was in November 2017. the dog presented to the veterinarian early january. on physical examination, the dog had darker brown skin and mild hairloss at the application site. the dog was also reported to be pruritic with sebborhea. the dog was treated with dexamethasone, sebborhea shampoo and antibiotics. the dog presented again in march with worse symptoms. CBC/biochem/thyroid panel performed in March 2018 was within normal limits.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
N - Unlikely
Reported hairloss at the application site may reflect local dermal sensitivity to the product. Darker brown skin at the application site is not expected when product applied as recommended. Pruritus is not expected to be generalised but rather be linked to the application site. Additionally seborrhea is not expected either. Other causes should be considered. Though time to onset is unknown, it seems long (more than 1 month) and considering overall aspects, a product connection is deemed to be unlikely.