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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6308

2. Registrant Information.

Registrant Reference Number: 2013CK079

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-JUN-13

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 .44 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 approximately 15-May-2013, a 16.5 year old, 17 pound, spayed female, Jack Russell Terrier canine, in good condition, with a concomitant medical condition of a snake bite incurred the previous year, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) once 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Jack Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16.5

7. Weight (provide a range if necessary )

17

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Lesion

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?

Unknown

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 approximately 01 June 2013 the dog developed a nonhealing skin lesion in the axillary region. She was seen by the attending veterinarian on an unknown date and treated with an unknown steroid injection and an unknown antibiotic cream. On approximately 22 Jun 2013 the dog passed away. No necropsy was performed. No more information is expected. Case is closed. Note: The intent of the phone call to Bayer Animal Health was not to report the death of this patient but to inquire about product expiration and application frequency.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Would not expect lesion development directly related to product, and affected skin area is not corresponding with the application site. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Time to onset very long, therefore allergic/anaphylactic reaction unlikely. Death likely related to other causes, allthough not reported. Dog is very old, therefore this may be a possible cause. The intent of the phone call to Bayer Animal Health was not to report the death of this patient but to inquire about product expiration and application frequency. Considering all aspects, product relation is deemed to be unlikely.