Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-6939
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0060268 (Report 446720)
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.
14-SEP-17
5. Location of incident.
Country: UNITED STATES
Prov / State: INDIANA
6. Date incident was first observed.
14-SEP-17
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 .44 %
7. b) Type of formulation.
Other (specify)
spot-on
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 12-Sep-2017, an 8 year old, 10 pound, neutered, male, Maltese/Poodle (Toy) crossbred canine, in unknown condition, with concomitant medical conditions of fleas and allergies, 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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
4.54
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Oral hemorrhage
- Skin
- Symptom - Burning skin
- Symptom - Other
- Specify - Atopic allergy NOS
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
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 14-Sep-2017 the dog had died in his kennel over night. The dog presented to the veterinarian deceased with oral cavity bleeding, a chronic skin allergy, and bruising on lateral aspect of both rear legs.
The dog was transported to (name) Animal Disease Diagnostic Lab at (name) University. No known necropsy had been performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Chronic skin allergy is not expected after product application. However, sign may be associated with concomitant medical condition of allergies. Bruising on leg may be consequence of skin allergies. Oral cavity bleeding and death are not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes are more probable. No signs of allergy/anaphylactic reaction reported. Occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Considering long time to onset (2 days), a product connection is deemed to be unlikely.