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Consumer Product Safety

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
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • 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

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.