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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0518

2. Registrant Information.

Registrant Reference Number: 2015CK026

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.

Unknown

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. Unknown

Product Name: k9 advantix II unknown

  • 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.

Unknown

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 an unknown date in Jul-2014, a 15 year old, 30 pound, neutered, male, Shetland Sheep Dog (Sheltie) canine, in unknown condition, with no known concurrent medical conditions, was bathed and then administered 1 tube of K9 Advantix II (unspecified) (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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

sheltie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

30

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 / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Itchy skin

12. How long did the symptoms last?

Persisted until death

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

Immediately post applicaiton the dog rolled on the ground (pruritus). The dog recovered 20 minutes later.On an unspecified date in July 2014 the dog died. 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

Pruritus is not expected to be generalized but rather be linked to the application site. Time to onset is short. However, it was also reported that the dog was bathed with an unknown shampoo, which might have also contributed to the sign. Reported death is not expected in dog after product application, as it is inconsistent with pharmaco-toxicological product profile. Very low level of information available e.g., condition of dog, time to onset is unknown and necropsy not performed. Thus, other etiologies are more probable. The owner initially contacted Bayer Animal Health to seek advise on bathing and not to report the death of this pet. Moreover, it was also reported that the dog was geriatric, which might have resulted in its death. Even though a positive re-challenge occurred for pruritus, considering overall aspects and that the dog had recovered from it, a product connection deemed to be unlikely.