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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2190

2. Registrant Information.

Registrant Reference Number: 2017KP134

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.

19-APR-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. 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 Jan-2012, a 12 year old, 13 pound,neutered, male, feline of unknown Breed and condition, with no known concomitant medical conditions, was administered1 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

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

13

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
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Seizure

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

On and unspecified date post application in Jan 2012 the cat had seizures. It is unknown if the cat was seen by a veterinarian, and if any treatments were performed. On an unspecified date in Jan-2012 the cat passed away. No further information is expected. Case is closed. Follow up received on 01 Mar 2017: No known necropsy was performed. Note: The intent of this call was not to report this event but to inquire on another product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Off label use (unauthorized species). Cat may have developed typical sign of intoxication after contact with permethrin. However, even though permethrin is toxic for cats and may have a fatal outcome, generally cats have a good chance to recover if adequate treatment is applied in time. It is unknown if anything was done in this case. Furthermore exact onset time is not known. No necropsy was performed. Moreover, the intent of this call was not to report this event but to inquire on another product. Other causes should also be considered in this geriatric cat. Considering unknown time to onset, a product connection is deemed to be unassessable.