Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2780
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0029846 (Report 495784)
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.
13-JUN-18
5. Location of incident.
Country: UNITED STATES
Prov / State: OHIO
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.
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 an unknown date in Oct2017, a 9.5 year old, 70 pound, neutered, female, German Shepherd Dog canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date in Nov2017, approximately 1 month post application, the canine developed behavioral changes and was administered 1 tube of K9 Advantix II Extra Large 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
German Shepherd Dog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
9.5
7. Weight (provide a range if necessary )
31.751
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Symptom - Death
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 an unknown date in Nov2017, approximately 1 month post application, the canine developed behavioral changes and was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.
An unspecified time post application, the same day, the canine recovered with no medical treatment.
On an unknown date in Dec2017, the canine died. No necropsy was performed.
No more information is expected this case is closed. The initial call was not to report the death of this canine, it was to discuss ticks on his other dogs.
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 behavioral changes are unspecific and may have numerous other causes in a dog. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very long time for reporting (more than 6 months) as the intent of the phone call to Bayer was not to report the death of this canine, but it was to discuss ticks on his other dog. Occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Time to onset is rather long (1 month). Other causes more probable. Considering overall aspects, a product connection is unlikely.