Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-0095
2. Registrant Information.
Registrant Reference Number: 2013CK144
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.
03-AUG-13
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
28-JUL-13
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. 27661
PMRA Submission No.
EPA Registration No.
Product Name: k9 Advantix 20
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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).
On 27-Jul-2013, a 4 year old, 22.00 pound, spayed, female, Unknown Breed canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 20 (Imidacloprid - Permethrin) once topically by the owner.On 27-Jul-2013, this dog was also administered an unknown amount of ivermecitn once orally by the owner
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
22
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Swelling
- Specify - periorbital edema
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
On 28Jul2013 the dog had periorbital edema, ocular erythema, and eye redness. On 29Jul2013 the dog was examined by the veterinarian and treated with diphenhydramine. On 30Jul2013 the dog was recovered. No further information is expected. Aug 8 - spoke with owner, the owner described the reaction as swelling around the eyes and of the face (cheeks and chin) as well as redness of the skin on the face. No redness of the eyes was noted
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Clinical signs ocular edema, ocular erythemia, and eye redness are non-specific in canines. The attending veterinarian suspicion was low, and felt the pet was stung by an insect or had other etiology. The signs resolved rapidly with minimal medical intervention.