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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0512

2. Registrant Information.

Registrant Reference Number: 2015CK020

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

19-JAN-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-OCT-14

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. 11556-144

Product Name: k9 advantix II extra large 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.

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 06-Oct-2014, a 17 year old, 72.00 pound, neutered female, Pit Bull canine, in good condition, with concomitant fleas, was administered 1 tube of K9 Advantix II Extra Large 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

pitbull

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

72

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia

12. How long did the symptoms last?

Persisted until death

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?

24

Hour(s) / Heure(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

One hour after product application the dog began vomiting. Approximately 8 hours later the dog was lethargic and ataxic. The dog was taken to the veterinary clinic and placed on intravenous fluids and administered unknown anti-nausea medications.7 Oct 2014 the dog passed away. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Even though consistent time to onset, vomiting is an unspecific sign in a dog and may have multiple potential causes. Potential oral uptake was not reported. Lethargy might be linked with the reported vomiting. Permethrin has the potential to cause slight neurological disorders e.g. ataxia in particular susceptible animals though, subsequent death is not expected after product application, as it is inconsistent with pharmacotoxicological product profile. Very low level of information available e.g. unknown underlying medical conditions and necropsy not performed. Thus, other unrelated etiologies more probable. No product quality issues were noted upon product investigation either. Dog was geriatric which might be the reason of its death. Considering consistent time to onset, a product connection remains unassessable