Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-2709
2. Registrant Information.
Registrant Reference Number: 2012TH054
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.
24-MAY-12
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
18-MAY-12
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. 27658
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix 10
PMRA Registration No. 27659
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix 100
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).
K9 advantix 10 (0.4 ml) was applied to a 1.5 yr old , 8.25 lb Poodle mix. K9 advantix 100 (4 ml) was applied to an 11 yr old, 75 lb lab mix.
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
Poodle X
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
8.25
lbs
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Symptom - Lesion
12. How long did the symptoms last?
Unknown / Inconnu
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 treated both dogs, a 1.5 yr old neutered male 8.25 lb poodle X with K9 advantix 10 and an 11 year old female spayed 75 lb Lab X with K9 advantix 100. The poodle X became itchy and scratch at his neck until it became raw. The dog was examined May 24 by a veterinarian and was still itchy. The raw spot was healing by this time. The owner had already bathed the dog in oatmeal shampoo. Benadryl was prescribed. The lab X was just a little itchy initially and was not examined.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
lab X
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
75
lbs
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
Unknown
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 treated both dogs, a 1.5 yr old neutered male 8.25 lb poodle X with K9 advantix 10 and an 11 year old female spayed 75 lb Lab X with K9 advantix 100. The poodle X became itchy and scratch at his neck until it became raw. The dog was examined May 24 by a veterinarian and was still itchy. The raw spot was healing by this time. The owner had already bathed the dog in oatmeal shampoo. Benadryl was prescribed. The lab X was just a little itchy initially and was not examined.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here