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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3999
2. Registrant Information.
Registrant Reference Number: 2015KP154
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.
20-JUL-155. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
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. 11556-141
Product Name: k9 advantix II small dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4Units: 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 May-2014, a 17 year old, neutered, male, Maltese canine, of unknown weight, in poor condition, with heart disease and a collapsing trachea, 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?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Dog / Chien
3. Breed
Maltese
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
17
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
- General
- Symptom - Death
- Cardiovascular System
- Symptom - Cardiac arrest
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
An unknown time following the application of product, in approximately May 2014, the dog exhibited cardiac arrest and died. No necropsy was performed. The caller contacted Bayer Animal Health to inquire about using the remainder of the product on their new pet and not to report this event. No more information is expected and the 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
Cardiac arrest and death reported later are not expected after product application as they are inconsistent with the product真真真s pharmaco-toxicological product profile. The dog in this case was a geriatric patient with poor condition and had a concomitant heart condition and a collapsing trachea, these were more likely be the cause of death rather than exposure to the product. No necropsy was performed. Moreover, the intent of the phone call to Bayer Animal Health to inquire about using the remainder of the product on their new pet and not to report this event. No signs of allergy/anaphylactic reaction reported. Even though time to onset is unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) is unlikely, as would have been reported in close proximity. Finally, considering the provided information including sign, chronology, the product真真真s pharmacological profile and the fact that an alternative cause was identified, a relation was deemed to be unlikely.
