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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0375

2. Registrant Information.

Registrant Reference Number: 2014CK055

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.

16-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-OCT-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.

1

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 03-Oct-2013, a 15 year old, 35 pound, intact, female, Bichon Frise canine, in good condition, with concomitant flea infestation, 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

bichon frise

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

35

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Bloody diarrhea
  • Nervous and Muscular Systems
    • Symptom - Coma
  • General
    • Symptom - Adipsia

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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 Oct 2013 the dog developed hemorrhagic diarrhea, adipsia and anorexia. Efforts were made to force feed the dog water and Gatorade.On 06 Oct 2013 the dog was in a comatose state.On 09 Oct 2013 the dog passed away.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Digestive tract disorders, e.g. vomiting and diarrhoea, rather unspecific in dogs and may have multiple potential causes. Not expected following topical application of product. Potential oral uptake not reported. However, even after ingestion, haemorrhagic diarrhoea is not expected, as inconsistent with pharmaco-toxicological product profile. Described course and signs rather argue for infectious cause or foreign body. Anorexia and adipsia also not expected and are likely linked to the other signs. Coma and death are also not expected after product application as inconsistent with pharmaco-toxicological product profile. Other etiologies are more probable, and it is more likely that the signs are a consequence of a rapidly progressing underlying disorder (e.g. infectious causes or corpus alienum). The dog's geriatric age may also have contributed to the fatal outcome. A necropsy was not carried out to investigate the cause. Finally, considering the signs and timely progression, thoughtime to onset consistent, a product connection is deemed unlikely.