Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5773
2. Registrant Information.
Registrant Reference Number: 2018TH077
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
26-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: ALBERTA
6. Date incident was first observed.
22-JUN-18
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. Unknown
Product Name: K9advantixII pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
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 21-Jun-2018, a 9 year old, 80 pound, neutered, male, Retriever - Golden dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of AdvantixII via the topical route by the animal 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
Golden Retriever
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
36.287
kg
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
- Gastrointestinal System
- Symptom - Anorexia
- Symptom - Vomiting
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?
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
On 22-Jun-2018 the dog exhibited intermittent vomiting and lethargy.
On 23-Jun-2018 the dog developed anorexia.
On 24-Jun-2018, the dog was bathed with an unspecified shampoo.
On 26-Jun-2018 the intermittent vomiting resolved. The dog was not evaluated by a veterinarian and no treatments were performed and the anorexia and lethargy continued.
Due to this is non- US registered product, no more information is expected and this case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
No assessment performed
The batch number was not provided, means we do not know which product was applied. Thus the minimal criteria is not fulfilled (no product), and the cases have to be classified as info case.