Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3327
2. Registrant Information.
Registrant Reference Number: 2011CP013
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
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.
11-FEB-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
05-JAN-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. 25130
PMRA Submission No.
EPA Registration No.
Product Name: ADVANTAGE 10 FLEA ADULTICIDE FOR DOGS 8 WEEKS AND OLDER WEIGHING 4.5KG
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).
one tube was applied to the dorsal midline
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
shih-tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
8.7
lbs
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 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
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
dog received advantage in Sept Oct and November without any side effects; rlocalised ulcers on foot pads and on nose , unknown how many feet are affected; appeared in early January 2011 biopsy results: nasal and digital parakeratosis; with dermatitis treated with: prednisone oral Baytril 25mg SID orally Metacam orally ; lesions appeared about 12 days after the December application;
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Affected skin areas do not correspond with the application site of product. If at all, skin reactions would be expected at the application site. Onset time is not suggestive of product involvement either. No adverse effects were noted after product application in September and October and November. Signs are not anticipated with product use and likely have other causes.