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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6293

2. Registrant Information.

Registrant Reference Number: 2013CK064

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.

12-JUN-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. 11556-143

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.

Liquid

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).

On 08-Jun-2013, a 11 month old, 60 pound, intact, male, Old English Bulldog canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner. This is an under dose for the animal.

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

Bulldog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.92

7. Weight (provide a range if necessary )

60

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Hives
    • Symptom - Erythema
    • Symptom - Hair loss
    • Symptom - Burns (superficial)
    • Specify - chemical burn
  • Respiratory System
    • Symptom - Other
    • Specify - respiratory tract infection - kennel cough
    • Symptom - Other
    • Specify - respiratory tract disorder

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Yes

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 08-Jun-2013, a 11 month old, 60 pound, intact, male, Old English Bulldog canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner. This is an under dose for the animal. On 12Jun2013 the dog had urticaria and application site erythema all along the back of the dog, hair loss around neck and jaw with an application site burn where product ran down from neck application site. Follow-up of 2013-07-31: On 16Jun2013 the dog was examined by the veterinarian, for chemical burn. The dog was given a dexamethasone injection, and was perscribed cefpodoxime, predisone, and a medicated shampoo. On 31Jul2013 the dog still had areas that were not resolved. Follow-up of 2013-08-29: On 01 Aug 2013 pet was examined again and treated with cephalexin and VCA Skinguard CP shampoo chlorhexidine 3%, climbazole 0.5%, Lipacide C8G, and phytosphingosinesalicyloyl. Follow-up of 2013-09-13: On an unspecified date the dog was diagnosed with kennel cough (respiratory tract infection) and was treated with an unspecified antibiotic. The dog was reverse sneezing when examined (respiratory tract disorder). On 06Sep2013 the owner found the dog was found dead in his kennel when traveling and stopped to let him out for a break. 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

Even though some of the initial skin disorders could be product related, respiratory disorders and respiratory infection are not expected as inconsistent with pharmacotoxicological product profile. Dog was diagnosed with kennel cough on an unspecified date and was reverse sneezing when examined in August. Dog was found dead in kennel when traveling 3 months after product application and death may be linked to respiratory infection or other medical condition. Considering all aspects, a product connection is deemed to be unlikely.