Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-5518
2. Registrant Information.
Registrant Reference Number: 2008CP031
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.
22-AUG-08
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
22-AUG-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. 25128
PMRA Submission No.
EPA Registration No.
Product Name: advantage 9
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).
1 tube of advantage 9 was applied to the back of the head on the dorsal midline
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
domestic short hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
Unknown
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
- Respiratory System
- Symptom - Difficulty Breathing
- Symptom - Dyspnea
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 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
Euthanised / Euthanasie
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
cat was dyspneic 14 hours after advantage application; product was applied correctly at back of head; no report of oral ingestion; mouth breathing; treated with injectable dexamethasone, lasix; did not respond and was euthanized; necropsy revealed pulmonary edema and congestion;
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here
advantage is non systemic and does not enter the body; discussed high level of safety of produt and no incidence of respiratory signs during safety studies;