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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6318

2. Registrant Information.

Registrant Reference Number: 2013CK089

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.

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. 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).

relevant details were not obtained nor will they be sought. On an unspecified date in 2011, a 12 year old, 20 pound, intact, female, Scottish Terrier canine, in fair condition, with atopic allergies and intermittent pruritus,was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner. This was the first time of use with the product.

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

Scottish Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

20

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Erythema
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Lesion

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 an unknown date post administration the owner noted scabs, erythema and skin lesions at the application site. The dog was also lethargic and developed vomiting and diarrhea. Approximately 1 month later the dog recovered from all clinical signs but had a scar at the application site. On an unspecified date in 2012 the dog passed away from unknown causes, as a necropsy was not performed. No further information expected. Case closed. Note: Specifics about the event were vague, as the caller had a hard time recalling specifics


To be determined by Registrant

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

Death

19. Provide supplemental information here

While application site erythema may occur in particular sensitive dogs after product application, scab and lesions at the application site are not expected. Dog likely, though not reported, scratched at site and caused skin lesions by selftrauma with subsequent development of scabs. The scar at application site, also unexpected, is a late consequence of skin disorders. However, duration of first course is unexpected long and the medical history conditions (atopic allergy and pruritus) of the dog may have contributed to the delayed recovery. For the reported lethargy and digestive disorders time to onset is unknown. Signs are very unspecific and dog is reported to be in fair condition. Other causes are more probable, but signs may have multiple potential causes in geriatric dogs (12 years). Death is not expected in dogs after product application, as inconsistent with pharmacotoxicological product profile. Very low level of information (unknown time to onset for death, no necropsy was performed) and details about the event were hard to remember for the owner. This is explainable by the fact, that last application of the product had been in 2011, patient died in 2012 and the report of the owner was received recently. Considering all aspects and point in time of owners call, a product connection is deemed to be unlikely.