Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0390
2. Registrant Information.
Registrant Reference Number: 2010CP068
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.
13-JUL-10
5. Location of incident.
Country: CANADA
Prov / State: NEW BRUNSWICK
6. Date incident was first observed.
06-JUL-10
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. 25131
PMRA Submission No.
EPA Registration No.
Product Name: advantage 100
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, in 4 spots
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
golden retreiver
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
37
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
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.
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
About 2 hours after application, dog's ears became red and face had some swelling; dog was rubbing face and ears on the floor;owner gave 1/2 tab Reactine, an antihistamine. the following day, the dog was examined: erythema on ears, face and at application sites; dog seemed pruritic in these areas. dog vomited 4 times that day. Treated with: 2 ml dexamethasone inj.( 2mg/ml) IV 1.4 ml benadryl inj. (50mg/ml) IV Benadryl tablets 2 1/2 tab (25 mg) orally TID x 2 d shampoo the dog Dog was treated with adavntage for 6 months in 2009 and did not have any reactions
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Dog was treated with adavntage for 6 months in 2009 and did not have any reactions