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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0536

2. Registrant Information.

Registrant Reference Number: 2017KP044

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-JAN-17

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. 11556-142

Product Name: k9 advantix II medium dog

  • 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.

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 an unspecified date in 2014, an 11 year old, 11 pound,intact, female, Terrier (Rat) canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium Dog (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

Rat Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

11

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 - Death
  • Gastrointestinal System
    • Symptom - Difficulty swallowing
  • Respiratory System
    • Symptom - Other
    • Specify - Respiratory Tract Disorder
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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 post application, in 2014, the dog exhibited trouble swallowing. The dog was evaluated by a veterinarian and diagnosed with an elongated soft pallet. The dog had surgery performed on an unspecified date. On an unspecified date post surgery, in 2014, the dog exhibited anorexia. The dog was examined by a veterinarian and was tube fed an unknown amount of food. On an unspecified date post onset of anorexia, in 2014, while being tube fed the dog aspirated and died. No necropsy was performed. The initial call to Bayer was to discuss product use on other animals and not to report this death. No more information is expected. This case is closed. Note: Previous applications were well tolerated.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Trouble swallowing is not expected after topical application of the product. However, sign likely consequence of diagnosed elongated soft palate. Anorexia likely associated to reported surgery. Reported death and elongated soft palate are not expected in dog after product application, as signs are inconsistent with pharmaco-toxicological product profile. However, death in this case likely a consequence of aspiration while being tube fed. Moreover, previous applications were well tolerated, and dog was of advanced age. Other causes are likely. Moreover, the intent of the call was to inquire product use on other animals and not to report this death. Finally, even though necropsy details and time to onset are unknown, considering the known product profile and sufficient information exists to conclude that the product did not cause the event and a product connection is deemed to be unlikely.