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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3059

2. Registrant Information.

Registrant Reference Number: 2013AM129

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.

22-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

18-MAR-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).

One vial of K9 Advantix II Large dog was applied topically by the owner to one spot on the dorsal midline.

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

Mastiff

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

.14

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Difficulty Breathing

12. How long did the symptoms last?

Persisted until death

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 18Mar2013, a 7 week old, 15 pound, intact, male, Mastiff canine, in good condition, with no known concomitant medical conditions, was in for an examination and was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) once topically by the attending vet. This patient was also administered 1/2 tablet of Drontal Plus Medium Tablet 68mg (praziquantel/pyrantel pamoate/febantel) once orally and received a distemper combo vaccination. On 19Mar2013 the puppy had difficulty breathing and was examined by another veterinarian, it is unknown if treatments were performed and the dog later passed away at the clinic. A necropsy was performed by the referring veterinarian with unknown results.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Described signs, and in particular death, not expected in dog after application of Advantix, as inconsistent with pharmacotoxicological product profile. Signs not expected even after overdosage in young puppy. Allergic/anaphylactic reaction to topically applied Advantix rather unlikely as indicative signs as e.g. erythema, hives and facial edema not reported. Time to onset short, but not completely indicative for anaphylactic reaction. Concomitant treatment with 2 other products performed. One of these (vaccine) more likely cause of potential anaphylactic reaction. Yet, signs not indicative as generally dogs show more digestive tract signs. Considering age of puppy and unknown disease and health status, including those of ancestors, signs and fatal outcome more likely related to hereditary disease or acute infection. However, with limited information (necropsy results missing) and due to short time to onset case not assessable.