Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2276
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0023226 (Report 487752)
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.
22-MAY-18
5. Location of incident.
Country: UNITED STATES
Prov / State: CONNECTICUT
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. 11556-144
Product Name: K9advantixII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
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 an unspecified date in approximately 2018, a female dog, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) 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
unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
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
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 a unspecified date in approximately 2018, post application, the dog died.
No knnown necropsy was performed.
No further information is expected. The case is closed.
Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the product use on another animal and not to report the death in this event.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Moreover, the intent of the phone call to Bayer was to discuss the product use on another animal and not to report the death in this event. No signs of allergy/anaphylactic reaction reported. Other causes are more probable. Even though low level of information (age, time to onset and necropsy details are not available), considering known product safety profile, a product connection is deemed to be unlikely.