Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3417
2. Registrant Information.
Registrant Reference Number: 2011TH021
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Road
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
26-MAY-11
5. Location of incident.
Country: CANADA
Prov / State: SASKATCHEWAN
6. Date incident was first observed.
24-MAY-11
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. 27661
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix 20
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).
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
Pomeranian X
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
9.8
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Paresthesia
- Symptom - Erythema
- Nervous and Muscular Systems
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
Owner applied K9 advantix to 2 dogs May 23 2011, by May 24, one dog was very itchy. This dog had used Defend last year with no concerns. On exam on May 25 2011 the veterinarian noted a 6 cm by 8 cm area of erythema. The dog was very agitated and would scream when the area was touched. The dog was trying to scratch the area. Vitamin E was applied and diazepam was prescribed along with metacam. The area was washed 3 times by the owner and once by the veterinarian. May 27 2011 the owners noted he was still itchy but not scratching as much and seemed calmer. He had scratched an area raw overnight and the owner returned to the clinic May 27 for another exam.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here