Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-1651
2. Registrant Information.
Registrant Reference Number: 208TH001
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.
16-OCT-07
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
10-OCT-07
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.
PMRA Submission No.
EPA Registration No.
Product Name: Advantage
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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).
Animal was treated with flea product, given flea bath and then advatage was applied. Despite several calls the the clinic they have not confirmed the dose that was given or the name of the other products used.
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
West Highland White Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
16.4
lbs
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
- Nervous and Muscular Systems
- Symptom - Muscle tremors
- Symptom - Recumbent
- Gastrointestinal System
- Symptom - Diarrhea
- Symptom - Salivating excessively
- Symptom - Retching
12. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 h
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
1
Day(s) / Jour(s)
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
Animal was exposed to at least one other flea product, clinic has not confirmed details. Pet fully recovered. Treated with fluids, dextrose, antibiotics and gastroprotectants. Clinical signs are indicative of a permethrin reaction, more likely caused by the other flea product(s) used.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here