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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6646

2. Registrant Information.

Registrant Reference Number: 2016KP192

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.

18-OCT-16

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.

4

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 an unknown date in 2012, a 5 year old, 20 pound,neutered, female, Crossbred canine, 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.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

20

lbs

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

  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Other
    • Specify - Digestive tract stenosis and obstruction

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

An unspecified time post administration in 2012, the dog was lethargic and vomited. It is unknown if she was examined or treated by a veterinarian. On an unknown date in 2012, the lethargy and vomiting resolved. On an unknown date in approximately 2016, the dog died. A necropsy was performed and the cause of death was determined to be a foreign body. No further information expected. Case closed. Note: The reporting party was not calling to report the death of the patient but mentioned during discussion of the product.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Reported vomiting is rather an unspecific sign and may have multiple potential causes. No oral uptake reported. Lethargy is likely a consequence of reported vomiting. Moreover time to onset was not reported. Death is not expected in a dog after product application, as it is inconsistent with pharmaco-toxicological product profile. Moreover, it is clearly reported that the cause of death was determined to be a foreign body. Actually, the reporting party was not calling to report the death of the patient but mentioned regarding the same during discussion of the product. Despite unknown time to onset for initially reported signs, overall, considering an exceptionally long time to onset (4 years) for reported death and the products known profile, a product connection is deemed to be unlikely.