Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3059
2. Registrant Information.
Registrant Reference Number: 2015CK066
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
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.
28-MAY-15
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
02-APR-15
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
- 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).
7.5yr 8.7kg mn miniature schnauzer was treated with K9 Advantix II medium dog on april 1st. The owner applied the k9 advantix on the back but it ran down the left side.
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
miniature schnauzer
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7.5
7. Weight (provide a range if necessary )
8.7
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Symptom - Hair loss
- Symptom - Erythema
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.
No
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
12 hours later, on april 2nd, the dog was itchy but not at the application site. The dog presented to an emergency clinic on april 3rd where the dog had a small patchy of swollen, erythematous skin on left side with alopecia. The dog was negative for external parasites. The dog was treated with topical antibiotic. The clinical signs persisted for approximately 72 hours before the dog was considered recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
previous history of symetrical lupos onchodystrophy managed with doxycycline, niacinamide, prednisone and tramadol. The dog was also receiving a prescription urinary diet for a history of bladder stones