Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-6288
2. Registrant Information.
Registrant Reference Number: 2015KP294
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Toronto
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.
19-OCT-15
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
06-SEP-15
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. 11556-141
Product Name: k9 advantix II Small dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
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 approximately 05-Sep-2015, a 6 month old, approximately 5.5 pound, intact, female, Dachshund canine, in good condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid- Permethrin-Pyriproxyfen) topically by the owner.
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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Dachshund (Standard)
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.6
7. Weight (provide a range if necessary )
5.5
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Melena
- Symptom - Diarrhea
- Symptom - Anorexia
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.
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 6-Sep-2015, the dog exhibited vomiting, black diarrhea, anorexia, and lethargy. On approximately 9-Sep-2015, the dog was deceased. No necropsy was performed. Follow-up received on 8 October 2015 : No further information expected. Case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Though most of signs may occur after product application, black diarrhea is not expected, even after product ingestion, as it is inconsistent with the pharmacotoxicological product profile. Further reported death is not expected either, even after oral uptake, and likely consequence of the reported signs. Described course and signs rather argue for an infectious cause, e.g. viral enteritis that is a common cause for the exhibited clinical signs and fatal outcome for this young patient. Finally, though necropsy not available and consistent time to onset for digestive signs, considering products pharmaco-toxicological profile and that signs likely reflect an infectious disease, a product connection is deemed to be unlikely.