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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-6073
2. Registrant Information.
Registrant Reference Number: 2014CK357
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.
Unknown
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. PMRA Submission No. EPA Registration No. 11556-125
Product Name: Advantage II medium dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1Units: 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 approximately 23-Mar-2014, a 9 year old, 12 pound, neutered, male, Poodle (Miniature) canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Medium Dog (Imidacloprid- Pyriproxyfen) topically by the owner.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
miniature poodle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
12
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
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
- Nervous and Muscular Systems
- Symptom - Paresis
12. How long did the symptoms last?
Persisted until death
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 an unknown date in April2014, the dog had lethargy. The dog was examined by a veterinarian and had a positive heartworm test. The dog was administered an unknown drug to kill the heartworms.On an unknown date later in April2014, the dog went limp and then died at home. 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
Lethargy is an unspecific sign and may have multiple potential other causes in an animal, it is not expected after long period of time. If any behavioral sign should occur, only shortly after product application. However, in this case other causes (positive heartworm test result reported) are more probable. Other reported signs (such as limping and death) are also not expected after topical product application and are inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. No necropsy was performed. Product has a wide margin of safety. Considering all aspects and use of concomitant drug reported, the cause for the serious outcome is unrelated to the product use and a product involvement considered to be unlikely.
