Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0388
2. Registrant Information.
Registrant Reference Number: 2010TH053
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield 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.
29-OCT-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
22-OCT-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. 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).
Owner applied product approx a week before contacting us but could not confirm how much time had passed between application and appearance of clinical signs
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
Cat / Chat
3. Breed
Domestic Long Hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
4.46
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Loss of appetite
- Symptom - Diarrhea
- Symptom - Vomiting
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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
Owner applied product approx a week prior to Oct. 29. On Oct 29 she contacted Bayer to advise her cat had been unwell for approx. 1 week. The cat was send by DVM Oct 29. 4 days of diarrhea, 1 vomiting event and dehydration was noted. The owner declined hospitalization or IV fluids but bloodwork was performed (normal) and subcutaneous fluids and tolfedine were given. The owner was advised the event was unrelated to advantage and the cat should be rechecked if not improving. Oct 30 the cat was seen by another veterinarian and again the owner declined IV fluids and hospitalization. Giardia was suspected. Cerenia and famotidine were given. The cat was reported to be improved by Nov 1 2010.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Moderate as treatment was given. Exposure listed as great than 4 weeks as product has at least 4 weeks activity.