Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2723

2. Registrant Information.

Registrant Reference Number: 2016KP041

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-MAY-16

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-133

Product Name: K9advantixII medium dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN

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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).

On an unspecified date in 2011, a 14 year old, 14 pound,male, Pekingese canine of unknown reproductive status, in unknown condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 20(Imidacloprid - Permethrin) topically by the owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pekingese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

14

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

• Eye
  • Symptom - Other
  • Specify - Retinal Atrophy

• Cardiovascular System
  • Symptom - Heart murmur
  • Symptom - Other
  • Specify - Heart Failure

• Nervous and Muscular Systems
  • Symptom - Stiffness

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

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 unspecified date in 2011, the canine was switched to K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. The owner continued to apply the product monthly on approximately the last day of each month. On an unspecified date in 2014, the canine was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unspecified date 2014, the canine, at approximately 15 years of age, was diagnosed with retinal atrophy by a veterinarian and began to have intermittent episodes of whole body stiffening. No known treatments were performed. On approximately 30Mar2015, the canine was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unspecified date in Apr2015, the canine was examined and diagnosed with a heart murmur and congestive heart failure. He was referred to a cardiologist. The canine died at home before the cardiologist was consulted. No known necropsy examination was performed. No further information is expected. This case is closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported signs are not expected as they are inconsistent with pharmaco-toxicological product profile. Death likely consequence of reported signs. Time to onset after Advantix application extremely long (over 3 years). Long time for reporting (over 8 months after death) as the intent of the phone call to Bayer was to ask if the product could be used on another pet, and not to report this adverse event. Other causes are more probable, e.g. geriatric status of the dog. Despite no necropsy was performed, considering exceptionally long time to onset, a product connection is deemed to be unlikely.