Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-6040
2. Registrant Information.
Registrant Reference Number: 2010TH028
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.
10-AUG-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
09-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. 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.
.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).
Owner applied to area just behind 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
Domestic Long Hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
15.5
7. Weight (provide a range if necessary )
4.7
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Lesion
- Symptom - Hair loss
- Symptom - Dermatitis
- Specify - ulcerative dermatitis
12. How long did the symptoms last?
>1 mo and <= 2mos / >1 mois et < = 2mois
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
Unknown/Inconnu
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 in late June or early July. Sometime between 7 days and three weeks later, the pet was groomed. Once the cat was shaved, the owners noticed a bald area. The pet was examined July 9 2010 and the veterinarian noted a lesion located caudal to the shoulder blades. This lesion was biopsied on July 12 2010 and found to be neutrophilic, eosiniophilic ulcerative dermatitis. This condition was thought to be possibly secondary to indiopathic ulcerative dermatitis or allergic skin disease and/or ectoparasites. The cat was treated with 3 injections of convenia and is healing well.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Exposure is listed as greater than a month as the product was not washed off. The cat is healing well and as of Aug 9 has shown good improvement.