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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-5406
2. Registrant Information.
Registrant Reference Number: 2014CK348
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.
20-OCT-145. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
14-JUN-14Product 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. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II Large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
- IMIDACLOPRID
PMRA Registration No. PMRA Submission No. EPA Registration No.
Product Name: Advantage (unspecified)
- Active Ingredient(s)
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 approximately 16-May-2014, a 5 year old, neutered, female, Siberian Husky crossbred canine, in good condition, with no known concomitant medical condition, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) topically by the owner. On approximately 13-Jun-2014, the dog had 1 tube of Advantage II for Large dogs (imidacloprid-pyriproxyfen) administered topically by the owner.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
siberian husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
Unknown
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
- Respiratory System
- Symptom - Respiratory distress
- Symptom - Panting
- General
- Symptom - Lethargy
- Symptom - Death
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.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
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 approximately 14-Jun-2014, the dog had panting and lethargy. On approximately 15-Jun-2014, the dog had respiratory distress and then was found deceased in the yard by the owner. No medical attention had been sought for this pet and no necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
No signs were seen after product use. First signs of panting and lethargy were reported approx. one month after product application. Respiratory distress and death not expected after product application, as inconsistent with pharmacotoxicological product profile. Other etiologies are more probable. No signs of allergy/anaphylactic reaction reported. Onset of signs shortly after application of another product. But overall, product involvement was ruled out.
