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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7484

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0067738 (Report 453404)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

16-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

15-OCT-17

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-151

Product Name: Advantage II Small Cat

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

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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).

A 3 year old, 7 pound, male, Domestic Longhair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

3.175

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

<=30 min / <=30 min

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On 15-Oct-2017, a 3 year old, 7 pound, male, Domestic Longhair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. 3 hours post application, the cat passed away. The feline was not examined by a veterinarian and no necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely 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. Even though time to onset is short. Considering known safety product profile and serious sign (death), a product involvement is deemed to be unlikely.