Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-3619
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2019-US0035027 (Report 577182)
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.
27-JUN-19
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
10-MAY-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. 11556-142
Product Name: K9advantixII medium 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.
1
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 01 May 2018, a 12 year old, 12 pound, neutered, female, Dachshund (Miniature) canine, in unknown condition, with a concomitant medical condition of seizures, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This dog continued to be applied the K9 Advantix II Medium Dog monthly with the last dose being on 01 Jul 2018.
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
Miniature Dachshund
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
5.443
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Liver
- Symptom - Elevated liver enzymes
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
Euthanised / Euthanasie
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 10 May 2018, the dog was examined by a veterinarian and bloodwork performed revealed elevated liver enzymes.
On 30 Oct 2018, the dog was examined by a veterinarian and blood work performed was within normal limits. The dog was administered an unspecified anti-nausea injection and placed on an anti-nausea oral medication.
On 20 Dec 2018, the dog exhibited vomiting.
On 07 Jan 2019, the dog was rechecked by the veterinarian, an ultrasound was performed and the canine was diagnosed with liver cancer and splenic cancer. The dog was euthanized. No known necropsy was performed.
Note: Previous exposure was well tolerated.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Elevated liver enzymes and later diagnosed liver and splenic cancer are not expected in dog after product application, as they are inconsistent with pharmaco-toxicological product profile. Other causes are more probable in this geriatric dog. Vomiting is unspecific sign and may be associated other reported signs. Need for euthanasia is not expected after product application. Owner may have elected to euthanize the dog due to underlying poor condition in this geriatric dog. Moreover, previous exposure was well tolerated. Time to onset is long. Considering overall aspects, a product connection is considered unlikely.