Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3601

2. Registrant Information.

Registrant Reference Number: 2016KP018

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.

15-JAN-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. Unknown

Product Name: advantage II - unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 approximately 2015, a 9 year old,17 pound, neutered, female, Domestic Longhair/Maine Coon Cat crossbreed feline, in good condition, with fleas was administered 1 tube of Advantage II (cat-unspecified)(Imidacloprid-Pyriproxyfen) 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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair/Maine Coon

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

17

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

• Respiratory System
  • Symptom - Laboured breathing

• Gastrointestinal System
  • Symptom - Weight loss

• Respiratory System
  • Symptom - Coughing
  • Symptom - Bronchitis

• General
  • Symptom - Other
  • Specify - Immune system disorders/Allergic conditions/Hypersensitivity reaction/Allergy NOS

• Respiratory System
  • Symptom - Asthma

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 approximately Jul2015 the cat had weight loss, coughing/ wheezing. The cat was examined by a veterinarian and was diagnosed with allergies and asthma. The cat was treated with an unknown steroid and was dewormed with an unknown medication. The owner began using a humidifier in the home. In Jul2015 the fleas continued and the cat was switched to an unspecified flea spray. On an unspecified date in 2015 the cat was gaining back weight. In Jan 2016 the cat was having difficulty breathing. On approximately 13Jan2016 the cat was found dead in the yard. No necropsy 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

Weight loss is neither expected nor in line with the pharmaco-toxicological product profile. Initially as well as later reported respiratory tract disorders are likely consequences of the immune disorders, which are unanticipated as well. Death is inconsistent with pharmaco-toxicological product profile. The product has a wide margin of safety. Rather, persistent breathing difficulties and exposure to the outdoors (yard) are suggestive of other causes (e.g asthma attack) for death. Although time to onset is unknown for initially reported signs, it is exceptionally long (several months) for later reported signs, including death. As product was applied only once at an unknown date lack of efficacy is not evident. Also unknown if correct pipette size was used. Overall, considering the prominent serious sign death, product relation is unlikely.