Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6121
2. Registrant Information.
Registrant Reference Number: 2018RB132
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-JUL-18
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
15-JUL-18
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: K9advantixII pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
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 15-Jul-2018, a 6 year old, 21 pound, neutered, male, Yorkshire Terrier/Bichon Frise crossbred canine, in unknown condition, with concomitant medical condition of anorexia, was administered 1 tube of K9 Advantix II (unspecified) (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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Crossbred (Yorkshire Terrier X Bichon Frise)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
9.52
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Symptom - Insomnia
- Specify - Not sleeping
- Skin
- Symptom - Edema
- Symptom - Erythema
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
Unknown/Inconnu
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
Approximately 1 hour post application the canine vomited one time.
Approximately 4 hours post application the canine had a generalized pruritus and was itching the application site and turning and looking at his back ( behavioral disorder NOS), and did not sleep, and had a swollen red foot.
On approximately 16-Jul-2018, the canine with bathed with an unspecified shampoo and administered diphenhydramine and the clinical signs continued. The canine was not examined by a veterinarian and no treatments were performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
B - Possible
Reported vomiting is more expected after oral uptake than after dermal application of the product. However, an inadvertent oral uptake cannot be excluded. Reported behavioural disorders are very unspecific and may have other causes. Pruritus is not expected to be generalised but rather be linked to the application site. However, this sign along with reported itching at the application site and reported behavioural disorders may be a consequence of the uncomfortable feeling caused by the applied product. Swollen red foot is not expected either and is likely a consequence of reported pruritus in this case. Considering consistent time to onset, a product connection is deemed to be possible.