Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6307

2. Registrant Information.

Registrant Reference Number: 2013CK078

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.

14-MAY-12

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.

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 13-May-2013, a 12 year old, 12 pound, neutered, male, Yorkshire Terrier canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) once 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

12

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Agitation

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Seizure

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 approximately 14-May-2013, the patient became agitated, was licking at the application site (application site pruritus), and was uncomfortable (behavioral). On 13-Jun-2013, 13-Jul-2013, and 23-Jul-2013, the owner applied doses of the product. On 03-Aug-2013, the patient began having diarrhea and was vomiting. On 04-Aug-2013, the dog began having seizures, then died. It is unknown whether or not a necropsy was performed. Follow-up on 6-Sep-2013: No further information is expected. 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

Reported application site pruritus and behavioural disorders may reflect paresthesia caused by permethrin and be a consequence of the uncomfortable feeling caused by the applied product. Vomiting and diarrhoea are rather unspecific in dogs and may have multiple potential causes. They are not expected following topical application of product. Potential oral ingestion was not reported. Late onset time (11 days after last product application). It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Late time to onset (12 days), and more likely coincidental occurrence or dog may have predisposition for idiopathic seizures. Death is not expected after product application. Long time to onset (12 days), therefore allergic/anaphylactic reaction unlikely. Death may be consequence of seizure. Considering all aspects, product relation is deemed to be unlikely.