Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2166

2. Registrant Information.

Registrant Reference Number: 2017KP110

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.

19-APR-17

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. 11556-127

Product Name: advantage II large dog

• 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.

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 an unspecified date in Oct 2016, a 6 year old, 12 pound,neutered, male, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered a partial tube of Advantage II Large Dog(Imidacloprid-Pyriproxyfen) 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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Neoplasia
  • Symptom - Cancer
  • Specify - Palpable mass

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 post application in Oct2016 the cat developed a mass. The cat was examined by a veterinarian and the mass continued to grow. The veterinarian performed a biopsy and diagnosed the mass as neoplasia. The cat died and it is unknown if a necropsy was performed. No further information is expected. This case is closed. Note: The intent of the call was to discuss product use on other pets and not to report the death of the cat.

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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

Off label use as dog product applied on cat. Mass, neoplasia and death are unexpected and inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Death likely consequence of rapid growing neoplasia. The product has no carcinogen potential. Moreover, the caller contacted Bayer Animal Health to discuss product use on another pet and not to report the death of the cat. Finally, even though some information (e.g. onset time, health status, necropsy results) are missing, considering known safety product profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.