Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-6004
2. Registrant Information.
Registrant Reference Number: 2008TH028
Registrant Name (Full Legal Name no abbreviations): Bayer Inc.
Address: 77 Belfied 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.
12-NOV-08
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
24-OCT-08
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. 25129
PMRA Submission No.
EPA Registration No.
Product Name: Advantage 18
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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).
Product was applied to cat's skin between the shoulder blades
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Siamese
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.66
7. Weight (provide a range if necessary )
5.4
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 - Hair loss
- Symptom - Discolouration
- Specify - hyperpigmentation
12. How long did the symptoms last?
>2 mos and <=6mos />2 mois et <=6mois
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
Owner used advantage for flea prevention. Product was applied between the shoulder blades. Approx 24 hours later the owner noticed some hair loss. The pet was examined and alopecia and slight hyperpigmentation was notices. No medical treatment was given. As of Nov 25, the cat was demonstrating no discomfort however the hair had not fully regrown. The examining doctor noted that this cat does barber and overgroom and hair regrowth elsewhere on the body is slow as well. An underlying allergy is suspected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Advantage is to be applied to the back of the head and neck when used in cats.