Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3233

2. Registrant Information.

Registrant Reference Number: US-BAYERBAH-2017-405830

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.

01-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

06-MAY-16

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. 11556-152

Product Name: Advantage II large cat

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

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7. b) Type of formulation.

Other (specify)

Spot-on solution

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).

Advantage II Large Cat 0.8 ml applied by animal owner. Weight of cat was unknown.

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

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Vocalizing

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Death

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?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

Event Narrative: Within 40 minutes of application, the cat vocalized once and then vomited one time. The cat had not been seen by a veterinarian. The cat was hit by a car and died an unknown time post application. No known necropsy was performed. :2016-06-02 10:59:07 : Case Notes: Used the language line, interpreter id #. The caller applied a panty on the cat to treat for flees. The cat was then hit by a car and killed. The caller was difficult to follow and did not allow for clarification what product she placed on the cat or in what time frame this occurred. The caller is wondering what the status of her reimbursement is. Reimbursement C#. No known necropsy was performed. No more information is e xpected. The 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

N - Unlikely A behavioural response to the product sensation or to the product smell may occur. Vomiting is an unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. Later reported death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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. The cat was hit by a car and died. Even though level of information is extremely low (necropsy result, time to onset), considering serious outcome and chronology, product relation is unlikely.