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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0513

2. Registrant Information.

Registrant Reference Number: 2015CK021

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.

04-SEP-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. 11556-141

Product Name: k9 advantix II small 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 02-Sep-2014, a 6 year old, 8 pound, neutered female, Yorkshire Terrier canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small 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

yorkshire terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

8

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
    • Symptom - Vocalizing

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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 04 Sept 2014 the dog became lethargic.On 07 Sept 2014 diarrhea ensued.On 09 Sept 2014 she was seen by the attending veterinarian for the clinical signs. An unspecified anti-diarrheal medication was prescribed.On 11 Sept 2014 the diarrhea resolved; however the dog remained lethargic.On 25 Sept 2014 the dog yelped once then 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

Reported lethargy, diarrhea and yelping are unspecific signs and may have multiple potential other causes in a dog. Potential oral uptake was not reported and no other digestive disorders which may reflect oral uptake, e.g. hypersalivation or vomiting, have been reported. Death is not expected in dog after product application, as it is inconsistent with pharmaco-toxicological product profile. Time to onset is long. Medical history and necropsy not available. Moreover, it was reported that the dog had the product applied monthly for several years without incidence. Thus, other etiologies more probable. Considering overall aspects, a product connection considered to be unlikely.