Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3790
2. Registrant Information.
Registrant Reference Number: 2011TH046
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.
18-JUL-11
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
08-JUL-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. 27660
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix 55
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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
Springer Spaniel
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
31.5
lbs
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Erythema
- Symptom - Lesion
- Specify - scab
- 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
Owner applied K9 advantix for first time June 20 2011. On July 8 2011, scabs were noted at the application site and the dog started to vomit and have diarrhea. The pet was examined for ongoing vomiting and diarrhea July 11 2011. Scabbing and erythema was noted over the shoulders and in one small patch on the left hind lateral thigh. The dog was bright and alert and normal otherwise. The affected area was clipped and cleaned. Vitamin E was applied to the shoulder and fuciderm to the lesion on the thigh. Metronidazole was prescribed for the diarrhea and low fat food was sent home
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here