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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4213

2. Registrant Information.

Registrant Reference Number: 2016KP117

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-JUL-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.

Unknown

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 Sep-2015, a 9 year old, female,Yorkshire Terrier canine, of unknown weight, reproductives tatus, and condition, with concomitant luxating patellas, 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

Unknown

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 - Anorexia
  • General
    • Symptom - Other
    • Specify - Abnormal Test Result

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?

Yes

14. b) How long was the animal hospitalized?

8

Day(s) / Jour(s)

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 in Oct 2015, the dog was lethargic. On unspecified dates in Oct 2015, Nov 2015, Dec 2015, Jan 2016 and Feb 2016, the product was reapplied. On an unspecified date post application, in Feb 2016, the dog was vomiting and not eating. On an unspecified date in Mar-2016 the product was reapplied. On an unspecified date post application, in Mar-2016, the dog was examined by a veterinarian and had a positive Lyme test. It is unknown what treatments were performed. On an unspecified date in Apr-2016 the product was reapplied. On 15-Apr-2016, the dog was referred to a veterinary teaching hospital and started on unspecified types of treatment. On 23-Apr-2016 the dog died. No known necropsy was performed. No further information is expected. Case is closed. Note: The intent of the call was to discuss product use on new pet and not to report the death of this dog.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported lethargy, vomiting and not eating are unspecific signs and may have numerous other causes in dog. Moreover signs likely linked to later diagnosed Lyme disease. Death reported after latest application, which is not expected as inconsistent with pharmaco-toxicological product profile, might be linked to diagnosed lyme disease or other causes more probable in an elderly dog, though no serious signs were reported to explain death. Moreover product was reapplied between the two applications followed by signs without any adverse events. Actually, the intent of the call was to discuss product use on new pet and not to report the death of this dog. Overall, though time to onset for signs are not provided and necropsy not available, considering Lyme diagnosis likely explain early signs, many applications were not followed by signs and death occurred long time after last application (over 8 days), a product connection is deemed to be unlikely.