Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-2068
2. Registrant Information.
Registrant Reference Number: 2011TH007
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.
04-APR-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
03-APR-11
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).
Owner applied product the morning of April 2 to one application site
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
Shih Tzu - Poodle
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
5.2
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Skin
- Symptom - Erythema
- Symptom - Hyperesthesia
- Nervous and Muscular Systems
- Symptom - Muscle twitching
- Skin
- Symptom - Other
- Specify - excoriation of lateral thorax
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 on Saturday AM to two dogs. Owners were busy all day but noticed dog was restless Sat night and trying to get onto owner's bed. Owner noticed on Sunday AM that dog's skin was twitchy. Examined by vet April 4. Vet noted be was hyperesthetic and there was mild erythema of the skin along with some mild excoriation of the lateral thorax from the dog's attempts to scratch. Steroids and antihistamines prescribed. I spoke with O April 5. Owner had not yet applied vitamin E and felt dog was much better. Veterinarian prescribed steroids (0.2 ml dex sq and 2.5 mg pred to start April 5 and tapering over next 9 days). Also gave 0.25 ml antihistamine SQ. Owner was advised to apply vitamin E but had not as of follow up April 5.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Classed as moderate as treatment given. Exposure shown as greater than 4 weeks as K9 advantix has at least 4 weeks activity.