Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6831
2. Registrant Information.
Registrant Reference Number: 2018CP261
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.
12-SEP-18
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
09-JUL-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. 29777
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII small dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
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 July 9 2018, a 2.3 kg,3 year old male neutered canine Yorkshire terrier was applied one tube K9advantixII small dog; a few hours after application, the dog had application site itching
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
2.3
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Bloody diarrhea
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?
Unknown
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
a few hours after application, the dog had application site itching; the day after application, the dog had bloody diarrhea; reaction lasted 5 days; dog was treated with oral metronidazole and oral fortiflora
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
O - Unclassifiable/unassessable - Application site itching likely reflects discomfort caused by the applied product. Even after ingestion, bloody diarrhea is not expected, as inconsistent with pharmaco-toxicological product profile. Described course and sign rather argue for infectious cause or foreign body. Though time to onset is short, considering overall aspects, a product connection is unassessable.