Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-5663
2. Registrant Information.
Registrant Reference Number: 2014CK434
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
20-OCT-14
5. 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. Unknown
Product Name: k9 advantix II unknown
- 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.
Unknown
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 2013, a male, Spaniel (Cocker) canine of unknown signalment, in unknown condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. The owner applied the product monthly.On an unknown date in 2013, approximately 1 month post application, the canine was diagnosed and died of an unspecified neoplasia. No known treatments were performed and it was unknown if a necropsy examination was performed
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
cocker spaniel
4. Number of animals affected
1
5. Sex
Male
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Neoplasia
12. How long did the symptoms last?
Persisted until death
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 2013, approximately 1 month post application, the canine was diagnosed and died of an unspecified neoplasia. No known treatments were performed and it was unknown if a necropsy examination was performed.Due to the sensitive nature of the communication, specific event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the efficacy of the product on her current dogs and not to report the death of this patient. No further information is expected. This 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
Unspecified neoplasia is not expected in dog after product use, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, weight, product details, medical history and necropsy unknown) as the reason for the initial call was to discuss the efficacy of the product on her current dogs and not to report the death of this patient. As reported, the dog was died due to the underlying disease (unspecified neoplasia) thus evidence of the progression of the dog's medical conditions. No signs of allergy/anaphylactic reaction reported. Time to onset is too long (1 month), occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Considering all aspects, product connection deemed to be unlikely.