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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2334
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0021311 (Report 486718)
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.
16-MAY-185. Location of incident.
Country: UNITED STATES
Prov / State: MARYLAND
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 (unspecified)
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- IMIDACLOPRID
7. b) Type of formulation.
Other (specify)
Spot onApplication 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 unspecified date in 2004, a 2.5 year old, male, Airedale Terrier canine, of an unknown weight and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) 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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Airedale Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.5
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
- Gastrointestinal System
- Symptom - Other
- Specify - Pancreas disorder
- General
- 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 unspecified date in 2004 the dog had an unspecified pancreatic disorder and was found deceased. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained. The reason for the phone call was to discuss product on a different pet and not to report the death in this event. No further information is expected. 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
N - Unlikely Reported pancreatic disorder and death are not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Systemic absorption of product is negligible. Very low level of information (medical history and time to onset are unknown, necropsy not available) as the intent of the phone call to Bayer was to discuss product use on a different pet, and not to report the events in this report 14 years ago. No signs of allergy/anaphylactic reaction reported. Considering all aspects, despite the lack of detailed information, product connection is deemed to be unlikely.
