Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0706

2. Registrant Information.

Registrant Reference Number: 2015KP341

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 spot-on (Unknown)

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 2001, a 17.5 year old, Boston Terrier crossbred canine, of unknown sex, weight, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) 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

Dog / Chien

3. Breed

Boston Terrier Crossbreed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

17.5

7. Weight (provide a range if necessary )

Unknown

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 - Neoplasia
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

No

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 post application, in 2001, the dog developed an unspecified cancer and died. It is unknown if a necropsy was performed. The caller contacted Bayer Animal Health to inquire about their current pet and not to report this event. No further information is expected. Case is closed. Note: Previous applications well tolerated.

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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

Unspecified cancer and reported death are not expected as inconsistent with product pharmaco toxicological profile. Time taken for reporting is long (14 year) as reporting of this adverse event likely done during the report of another adverse event in another dog with another product. Low level of information (product details, time to onset, absence of necropsy results) as reason for the initial call to Bayer Animal Health was to inquire about their current pet and not to report this event. Dog tolerated previous applications well. Dog must have died due to poor prognosis or an old age. Considering all aspects, a product connection is deemed to be unlikely.