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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4926

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0041344

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.

10-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

26-JUN-17

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. 11556-143

Product Name: K9 Advantix II Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

Spot-on

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).

A 14 year old, 25 pound, neutered, male, Crossbred Canine, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of K9 Advantix II 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

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

11.34

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Bloody diarrhea
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Weakness
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Specify - unable to stand

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Yes

14. a) Was the animal hospitalized?

No

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-Jun-2017, a 14 year old, 25 pound, neutered, male, Crossbred Canine, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On approximately 26-Jun-2017 the canine was weak, unable to stand, anorexic and developed bloody diarrhea. The canine was taken to the vet and placed on unknown antibiotics but passed away later that afternoon. No necropsy was performed. No further information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Reported bloody diarrhoea is not expected even after ingestion, as inconsistent with pharmaco-toxicological product profile. Described sign rather argue for infectious cause or foreign body. Reported weakness and anorexia are rather unspecific and may be consequence of bloody diarrhoea. Though permethrin has the potential to cause slight neurological disorders like unable to stand in particular susceptible animals, time to onset is too long in this case. Thus other causes should be considered. Reported death is not expected either in dog after product application, as inconsistent with pharmaco-toxicological product profile. Geriatric age of the dog and underlying disease should be considered for death. No signs of allergy/anaphylactic reaction reported. Considering all aspects, especially the chronology product connection deemed to be unlikely.